A Comparative Study of Bilateral Transverse Abdominis Plane Block, Rectus Sheet Block and Combined TransversusAbdominis Plane Block and Rectus Sheath Block for Post-Operative Pain Management in Elective LaparoscopyCholecystectomy
Comparative Study of Bilateral Transverse Abdominis Plane Block, Rectus Sheet Block and Combined Transversus Abdominis Plane Block and Rectus Sheath Block for Post-Operative Pain Management in Elective Laparoscopy
Cholecystectomy
Design
The current study is a double-blind clinical trial study that will be conducted in parallel. A total of 129 laparoscopic cholecystectomy patients will be included in the study. Eligible patients are randomly divided into three equal groups of T, R and C.
Settings and conduct
Patients who are candidates for laparoscopic cholecystectomy who visit Bo Ali Sina Hospital in Shiraz during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method. This study will be conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA grade I or II, patients between 4 and 10 years old and Candidate for Laparoscopy Cholecystectomy.
Conditions of non-entry: allergy to the drugs used in the study, abnormal bleeding, patients suspected of severe adhesions, history of heart, respiratory, kidney diseases and addiction, obesity with a BMI greater than 33 and pregnancy or breastfeeding.
Intervention groups
In all three groups, after the induction of anesthesia, the patients will be given the pain-relieving regimen, which includes 20 cc syringes containing 5 cc of ropivacaine 5% plus 15 cc of distilled water, which will be injected into each rectus sheet in group (R). In group (T), it is injected at the level of the transverse abdominis muscle, and in group (C) it is injected in the form of a combination of 10 per rectus sheet and 10 cc at the level of the transverse abdominis muscle.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230215057420N1
Registration date:2024-08-17, 1403/05/27
Registration timing:prospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
َAli Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
akbaria@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-01, 1403/06/11
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Bilateral Transverse Abdominis Plane Block, Rectus Sheet Block and Combined TransversusAbdominis Plane Block and Rectus Sheath Block for Post-Operative Pain Management in Elective LaparoscopyCholecystectomy
Public title
A comparative study of pain management in closing the passageway of the pain nerve message of the transverse abdominal plate, in front of the rectus sheath, and the combination of closing the passageway of the transverse abdominal plate and the rectus sheath after gallbladder removal.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 20 and 70 years old
Candidate for Laparoscopy Cholecystectomy
Exclusion criteria:
Allergy to the drugs used in the study
Abnormal bleeding
Patients suspected of severe adhesions
Positive history of Heart, respiratory, kidney diseases and addiction
Obesity with a BMI greater than 33
Pregnancy or breastfeeding
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into three groups. In this method, patients will be allocated randomly and equally divided into three groups A, B, and C based on permutation blocks of three with (۴۵۰۳۳۶۵۱۰۴۰۹۸۲) Seed number. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the operating room, all study drugs will be provided by the only person familiar with the study (Nurse anesthetist).
The pain service anesthesiologist will perform only the nerve block and general anesthesia, while another independent anesthesiologist, blinded to randomization and anesthesia results, will only review and record the study variables. so,The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School.
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.SUMS.MED.REC.1403.033
Health conditions studied
1
Description of health condition studied
Choronic Cholecystitis
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
Pain after surgery
Timepoint
1, 2, 4, 6, 12, 18 and 24 hours after surgery.
Method of measurement
Numerical Rating Scales(NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group R: rectus sheath block (RSB block):In all three groups, after the induction of anesthesia, the patients will be given the painkiller regimen under study, which includes 20 cc syringes containing 5 cc of Ropivacaine 5% plus 15 cc of distilled water, which will be injected into each rectus sheet in group (R).
Category
Treatment - Surgery
2
Description
Intervention Group T: Transverse abdominal muscle surface block (TAP block): After the induction of anesthesia, the patients will be given the pain-relieving regimen, which includes 20 cc syringes containing 5 cc of Ropivacaine 5% plus 15 cc of distilled water, which will be injected in group (T) at the level of the transverse abdominis muscle.
Category
Treatment - Surgery
3
Description
Group (C): The combination group of transverse abdominal plane block and rectus sheath block: Like two groups T and R, a combination of 10 cc of Ropivacaine solution is injected from a 20 cc syringe in each rectus sheet and 10 cc in the transverse abdominal muscle.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
Mehdi Maher
Street address
No. 958, Pasdaran Blvd, New Sadra City, Shiraz.
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 1249
Email
abualisinacharity@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?