Comparing the effect of oral pregabalin administration before surgery with placebo on pain after laparoscopic surgeriesEndometriosis of women in Rasoul Akram Hospital (S): a clinical trial study
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Protocol summary
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. All patients receive 2 grams of Apotel intravenously after the operation, and pethidine is taken one dose the night before and one dose one hour before the operation.
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia.All patients receive pethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is compared.
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. Allanesthesia.All patients receive 2 grams of Apotel intravenously after the operationpethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is taken one dose the night before and one dose one hour before the operationcompared.
برای گروه مداخله داروی پرگابالین خوراکي ( 150mg, single dose) و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهد گردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد. همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریافت میكنند و پتدین یك دوز شب قبل و یك دوز هم یك ساعت قبل از عمل مصرف مي شود.
برای گروه مداخله داروی پرگابالین خوراکي ( 150mg, single dose) و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهد گردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.در تمام بیماران در صورت درخواست پتدین به عنوان مسکن پس از جراحی دریافت می کنند و دوز تجمیعی پتدین دریافتی در دو گروه تحت مقایسه قرار می گیرد.
برای گروه مداخله داروی پرگابالین خوراکي ( 150mg, single dose) و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهد گردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد. همهشد.در تمام بیماران 2 گرم آپوتل وریدی بعددر صورت درخواست پتدین به عنوان مسکن پس از عملجراحی دریافت میكنندمی کنند و دوز تجمیعی پتدین یك دوز شب قبل و یك دوز هم یك ساعت قبل از عمل مصرف مي شوددریافتی در دو گروه تحت مقایسه قرار می گیرد.
General information
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اصلاح روش اجرا
اصلاح روش اجرا
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. Placebo is completely similar to the original drug and its chemical composition is different. All patients receive 2 grams of Apotel intravenously after the operation, and pethidine is taken one dose the night before and one dose one hour before the operation.
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. Placebo is completely similar to the original drug and its chemical composition is different.All patients receive pethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is compared.
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. Placebo is completely similar to the original drug and its chemical composition is different. Alldifferent.All patients receive 2 grams of Apotel intravenously after the operationpethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is taken one dose the night before and one dose one hour before the operationcompared.
برای گروه مداخله داروی پرگابالین خوراکي (150mg, single dose )و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهدگردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد. دارونما کاملا شبیه داروی اصلي است و تقط نروعماده شیمیایي آن متفاوت است. همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریاتت میكنن و پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شود.
برای گروه مداخله داروی پرگابالین خوراکي (150mg, single dose )و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهدگردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد. دارونما کاملا شبیه داروی اصلي است و فقط در ماده شیمیایي آن متفاوت است.در تمام بیماران در صورت درخواست پتدین به عنوان مسکن پس از جراحی دریافت می کنند و دوز تجمیعی پتدین دریافتی در دو گروه تحت مقایسه قرار می گیرد.
برای گروه مداخله داروی پرگابالین خوراکي (150mg, single dose )و برای گروه کنترل دارونما (کپسول حاوی نشاسته) تجویز خواهدگردید. دارو و دارونما 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد. دارونما کاملا شبیه داروی اصلي است و تقط نروعمادهفقط در ماده شیمیایي آن متفاوت است. همهاست.در تمام بیماران 2 گرم آپوتل وریدی بعددر صورت درخواست پتدین به عنوان مسکن پس از عمل دریاتت میكننجراحی دریافت می کنند و دوز تجمیعی پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شوددریافتی در دو گروه تحت مقایسه قرار می گیرد.
Intervention groups
#1
Intervention group: In the intervention group, oral pregabalin, a single dose of 150 mg, will be given to the patients one hour before the start of general anesthesia. All patients will receive 2 grams of Apotel intravenously after the operation, and one dose of pethidine the night before and one dose one hour before the operation. In terms of the amount of pain, they will be assessed by the visual pain assessment questionnaire (VAS).
Intervention group: In the intervention group, oral pregabalin, a single dose of 150 mg, will be given to the patients one hour before the start of general anesthesia. questionnaire (VAS).
Intervention group: In the intervention group, oral pregabalin, a single dose of 150 mg, will be given to the patients one hour before the start of general anesthesia. All patients will receive 2 grams of Apotel intravenously after the operation, and one dose of pethidine the night before and one dose one hour before the operation. In terms of the amount of pain, they will be assessed by the visual pain assessment questionnaire (VAS).
گروه مداخله:در گروه مداخله پرگابالین خوراکی تک دوز 150mg یک ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریافت میكنند و پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شود.از نظر میزان درد بوسیله پرسشنامه ارزیابي درد بصری (VAS )قرار خواهند گرفت.
گروه مداخله:در گروه مداخله پرگابالین خوراکی تک دوز 150mg یک ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.
گروه مداخله:در گروه مداخله پرگابالین خوراکی تک دوز 150mg یک ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریافت میكنند و پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شود.از نظر میزان درد بوسیله پرسشنامه ارزیابي درد بصری (VAS )قرار خواهند گرفتشد.
#2
Control group: In the control group, placebo (capsule containing starch) will be given to the patients 1 hour before the start of general anesthesia. placebo is completely similar to the original drug and only the type of chemical substance is different. All patients receive 2 grams of Apotel intravenously after the operation, and pethidine is taken one dose the night before and one dose one hour before the operation.
Control group: In the control group, placebo (capsule containing starch) will be given to the patients 1 hour before the start of general anesthesia. placebo is completely similar to the original drug and only the type of chemical substance is different.
Control group: In the control group, placebo (capsule containing starch) will be given to the patients 1 hour before the start of general anesthesia. placebo is completely similar to the original drug and only the type of chemical substance is different. All patients receive 2 grams of Apotel intravenously after the operation, and pethidine is taken one dose the night before and one dose one hour before the operation.
گروه کنترل:در گروه کنترل دارو نما (کپسول حاوی نشاسته) 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.داروتما کاملا شبیه داروی اصلي است و فقط نوع ماده شیمیایي آن متفاوت است. همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریافت میكنن و پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شود
گروه کنترل:در گروه کنترل دارو نما (کپسول حاوی نشاسته) 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.دارونما کاملا شبیه داروی اصلي است و فقط نوع ماده شیمیایي آن متفاوت است.
گروه کنترل:در گروه کنترل دارو نما (کپسول حاوی نشاسته) 1 ساعت پیش از شروع بیهوشي عمومي به بیماران داده خواهد شد.داروتماشد.دارونما کاملا شبیه داروی اصلي است و فقط نوع ماده شیمیایي آن متفاوت است. همه بیماران 2 گرم آپوتل وریدی بعد از عمل دریافت میكنن و پتدین یك دوز شب قبل و یك دوز هم یكساعت قبل عمل مصرف مي شود
Recruitment centers
#1
Name of recruitment center - English: Rasool Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم (ص)
Full name of responsible person - English: Elnaz Aghabeigi
Full name of responsible person - Persian: الناز آقابیگی
Street address - English: Tehran Hemat Highway next to Milad Tower
Street address - Persian: تهران، اتوبان همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Fax: +98 912 466 1996
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasool Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم (ص)
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز آقابیکی
Street address - English: Tehran Hemat Highway next to Milad Tower
Street address - Persian: تهران، اتوبان همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Fax: +98 912 466 1996
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasool Akram Hospital Name of recruitment center - Persian: بیمارستان رسول اکرم (ص) Full name of responsible person - English: Elnaz AghabeigiAghabeiki Full name of responsible person - Persian: الناز آقابیگیآقابیکی Street address - English: Tehran Hemat Highway next to Milad Tower Street address - Persian: تهران، اتوبان همت غرب، جنب برج میلاد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 912 466 1996 Fax: +98 912 466 1996 Email: aghabeigi.e@iums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز اقابیکی
Street address - English: tehran hemat highway next to milad tower ,
Street address - Persian: تهران بزرگراه شهید همت غرب بین تقاطع شیخ فضل الله و شهید چمران نوری144
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8855 0681
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز اقابیکی
Street address - English: Tehran Hemmat highway next to Milad tower
Street address - Persian: تهران بزرگراه شهید همت غرب بین تقاطع شیخ فضل الله و شهید چمران نوری144
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8855 0681
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elnaz Aghabeiki Full name of responsible person - Persian: الناز اقابیکی Street address - English: tehran hematTehran Hemmat highway next to miladMilad tower , Street address - Persian: تهران بزرگراه شهید همت غرب بین تقاطع شیخ فضل الله و شهید چمران نوری144 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8855 0681 Fax: Email: aghabeigi.e@iums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeigi
Full name of responsible person - Persian: الناز آقابیگی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز آقابیکی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elnaz AghabeigiAghabeiki Full name of responsible person - Persian: الناز آقابیگیآقابیکی Position - English: Obstetrics and Gynecology Assistant Position - Persian: دستیار زنان و زایمان Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran Hemat Highway next to Milad Tower Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 912 466 1996 Mobile: +98 912 466 1996 Fax: Email: aghabeigi.e@iums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeigi
Full name of responsible person - Persian: الناز آقابیگی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower، 14535
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز آقابیکی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower، 14535
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elnaz AghabeigiAghabeiki Full name of responsible person - Persian: الناز آقابیگیآقابیکی Position - English: Obstetrics and Gynecology Assistant Position - Persian: دستیار زنان و زایمان Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran Hemat Highway next to Milad Tower، 14535 Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 912 466 1996 Mobile: +98 912 466 1996 Fax: Email: aghabeigi.e@iums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeigi
Full name of responsible person - Persian: الناز آقابیگی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower، 14535
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elnaz Aghabeiki
Full name of responsible person - Persian: الناز آقابیکی
Position - English: Obstetrics and Gynecology Assistant
Position - Persian: دستیار زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Tehran Hemat Highway next to Milad Tower، 14535
Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 912 466 1996
Mobile: +98 912 466 1996
Fax:
Email: aghabeigi.e@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elnaz AghabeigiAghabeiki Full name of responsible person - Persian: الناز آقابیگیآقابیکی Position - English: Obstetrics and Gynecology Assistant Position - Persian: دستیار زنان و زایمان Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Tehran Hemat Highway next to Milad Tower، 14535 Street address - Persian: تهران، اتوبان شهید همت غرب، جنب برج میلاد City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 912 466 1996 Mobile: +98 912 466 1996 Fax: Email: aghabeigi.e@iums.ac.ir Web page address:
Protocol summary
Study aim
Awareness of the effectiveness and safety of using oral pregabalin in reducing the pain of patients undergoing laparoscopic endometriosis surgery can help clinical specialists in reducing the need to prescribe opioid drugs and also reduce the risk of negative side effects caused by the use of opioid drugs.
Design
The clinical trial has a control group, with parallel groups, randomized phase 3 on 100 patients. For randomization, we use the blocking function with a block size of 4 with equal probability to enter eligible patients.
Settings and conduct
A randomized clinical trial study in women between 18 and 45 years of age who referred to Rasul Akram Hospital for laparoscopic endometriosis surgery between 1401 and 1402. Due to the fact that the doctor performing the laparoscopy is aware of the intervention, blinding is impaired.
Participants/Inclusion and exclusion criteria
The inclusion criteria in this study are:
Patients aged between 18-45 years
All patients who are candidates for laparoscopic endometriosis surgery.
Absence of drug addiction in the patient.
Intervention groups
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia.All patients receive pethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is compared.
Main outcome variables
length of surgery, length of anesthesia, pain score, level of pethidine use after surgery, nausea and vomiting, patient satisfaction
General information
Reason for update
Modifying the execution method
Acronym
IRCT registration information
IRCT registration number:IRCT20230812059132N1
Registration date:2023-11-05, 1402/08/14
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:1
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
Elnaz Aghabeiki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8855 0681
Email address
aghabeigi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of oral pregabalin administration before surgery with placebo on pain after laparoscopic surgeriesEndometriosis of women in Rasoul Akram Hospital (S): a clinical trial study
Public title
The effect of pre-operative oral pregabalin on pain after laparoscopic surgeries for endometriosis in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-45 years
All patients who are candidates for laparoscopic endometriosis surgery
Absence of drug addiction in the patient
Lack of chronic and long-term use of opioid drugs or painkillers such as tramadol, diclofenac, naproxen
Do not have psychiatric problems
Insensitivity to pregabalin
Performing surgery between 1401 and 1402 in Rasul Akram Hospital
Exclusion criteria:
have a contraindication for laparoscopy
Have liver or kidney problems
BMI above 30
Not able to express VAS score
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this part of the study, all patients are blindly divided into two groups based on the random blocking process.
We use blocking randomization with a block size of 4 with equal probability to enter eligible patients in these two treatment groups.
Given the block size of 4, we have six possible combinations for assigning people to groups, which include AABB, ABAB, BAAB, BABA, BBAA, ABBA.
At the beginning of the study, we randomly select one of these arrangements using randomization calculator, and four eligible inpatients are placed in each block. We repeated this process several times until all eligible patients were studied.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Oral pregabalin (150 mg, single dose) will be prescribed for the intervention group and placebo (capsule containing starch) will be prescribed for the control group. Medicine and placebo will be given to patients 1 hour before the start of general anesthesia. Placebo is completely similar to the original drug and its chemical composition is different.All patients receive pethidine as a post-surgery pain reliever upon request, and the cumulative dose of pethidine received in the two groups is compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-09-23, 1402/07/01
Ethics committee reference number
IR.iums.fmd.rec.1401.247
Health conditions studied
1
Description of health condition studied
Laparoscopic surgeries for endometriosis in women
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Pain
Timepoint
All patients in two groups are evaluated after surgical recovery and immediately after recovery and at 2, 6, 12, 24 and 48 hours after surgery.
Method of measurement
In terms of the amount of pain, they will be assessed by the visual pain assessment questionnaire (VAS).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, oral pregabalin, a single dose of 150 mg, will be given to the patients one hour before the start of general anesthesia. questionnaire (VAS).
Category
Treatment - Drugs
2
Description
Control group: In the control group, placebo (capsule containing starch) will be given to the patients 1 hour before the start of general anesthesia. placebo is completely similar to the original drug and only the type of chemical substance is different.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Elnaz Aghabeiki
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 466 1996
Fax
+98 912 466 1996
Email
aghabeigi.e@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Aghabeiki
Street address
Tehran Hemmat highway next to Milad tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8855 0681
Email
aghabeigi.e@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Aghabeiki
Position
Obstetrics and Gynecology Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 466 1996
Email
aghabeigi.e@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Aghabeiki
Position
Obstetrics and Gynecology Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 466 1996
Email
aghabeigi.e@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Aghabeiki
Position
Obstetrics and Gynecology Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 466 1996
Email
aghabeigi.e@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Due to the lack of information regarding the effect of pre-surgery administration of this drug on recovery in patients, we decided to conduct a randomized clinical trial study to investigate and evaluate the effectiveness and safety of a single pre-operative dose of pregabalin on the amount of postoperative pain. Let's talk about the operation of patients in laparoscopic endometriosis surgeries in Rasul Akram Hospital. The information obtained from this research will help to reduce the pain of these patients and also reduce the side effects caused by the use of opioid drugs.
When the data will become available and for how long
Our 6th access period starts after the results are published
To whom data/document is available
All gynecologists and obstetricians and people who work in this field.
Under which criteria data/document could be used
6 months after the publication of the article, all data will be usable.