Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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length of surgery, length of anesthesia, pain score, level of pethidine use after surgery, nausea and vomiting, patient satisfaction
General information
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Reason for update
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Modifying the execution method
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Acronym
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IRCT registration information
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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
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Registration date
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2023-11-05, 1402/08/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-22, 1402/09/01
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Expected recruitment end date
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2024-01-20, 1402/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of pre-operative oral pregabalin on pain after laparoscopic surgeries for endometriosis in women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2023-09-23, 1402/07/01
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Ethics committee reference number
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IR.iums.fmd.rec.1401.247
Health conditions studied
1
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Description of health condition studied
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Laparoscopic surgeries for endometriosis in women
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ICD-10 code
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N80
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ICD-10 code description
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Endometriosis
Primary outcomes
1
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Description
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Pain
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Timepoint
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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.
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Method of measurement
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In terms of the amount of pain, they will be assessed by the visual pain assessment questionnaire (VAS).
Intervention groups
1
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Description
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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).
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Our 6th access period starts after the results are published
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To whom data/document is available
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All gynecologists and obstetricians and people who work in this field.
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Under which criteria data/document could be used
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6 months after the publication of the article, all data will be usable.
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From where data/document is obtainable
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Elnaz Aghabeigi, Email address: aghabeigi.e.iums.ac.ir
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What processes are involved for a request to access data/document
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6 months after the results of the study are published, people can receive the data files via email to the email address aghabeigi.e@iums.ac.ir.
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Comments
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