Comparison of the effect of rectus sheet block and Transversus abdominis plane with ropivacaine on postoperative pain management in laparoscopic cholecystectomy patients
Comparison of the effect of rectus sheet block and Transversus abdominis plane with ropivacaine on postoperative pain management in laparoscopic cholecystectomy patients
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 68 patients who will be undergoing Claparoscopic cholecystectomy will be enrolled. Eligible patients will be randomly allocated into two equal A and B groups by block randomization.
Settings and conduct
Patients who are candidates for laparoscopic cholecystectomy who visit Abu Ali Sina Organ Transplantation 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, so that the patients, researcher and the outcome assessor will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA grade I or II (American Society of Anesthesiology classification), Patients between 18 and 65 years old and Candidate for laparoscopic cerebrocystectomy surgery.
Exclusion criteria:Positive history of previous abdominal surgery, Positive history of continuous use of painkillers, Patients with acute cholecystitis, addiction, peripheral neuropathy, Pregnant women and Allergy to the drugs used in the study.
Intervention groups
Group patients (TAP block): In this group, TAP block is performed by anesthesiologist under ultrasound guidance with 30 ml of 0.2% ropivacaine, 15 cc on each side.
Group patients (RSB): For RSB, the ultrasound probe will be placed transversely on the right abdominal muscle, below the umbilicus, and the block will be performed symmetrically on both sides by injecting 15 ml of ropivacaine 0.2% on each side by the attending anesthetist. will be.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043550N5
Registration date:2024-04-05, 1403/01/17
Registration timing:prospective
Last update:2024-04-05, 1403/01/17
Update count:0
Registration date
2024-04-05, 1403/01/17
Registrant information
Name
Ashkan Panah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
panah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-01, 1403/02/12
Expected recruitment end date
2025-01-01, 1403/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rectus sheet block and Transversus abdominis plane with ropivacaine on postoperative pain management in laparoscopic cholecystectomy patients
Public title
Comparison of the effect of rectus abdominis muscle block and transversus abdominis muscle block by ropivacaine on postoperative pain in gallstone surgery patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 18 and 65 years old
Candidate for laparoscopic cerebrocystectomy surgery
Exclusion criteria:
Positive history of previous abdominal surgery
Positive history of continuous use of painkillers
Positive history of using adrenergic receptor agonist and antagonist drugs
Patients with acute cholecystitis, addiction, peripheral neuropathy, bradycardia, high blood pressure and low blood pressure
Pregnant women
Allergy to the drugs used in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups A and B by throwing a dice.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person participating in the study, the researcher and the outcome assessor will be unaware of the type of blocks. Syringes have no markers indicating group assignment.
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
7134844119
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1402.311
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Pain
Timepoint
at 0, 2, 4, 8, 12, 18 and 24 hours after the operation.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Group patients (TAP block): In this group, TAP block is performed by anesthesiologist under ultrasound guidance with 30 ml of 0.2% ropivacaine, 15 cc on each side.
Category
Treatment - Other
2
Description
Group patients (RSB): For RSB, the ultrasound probe will be placed transversely on the right abdominal muscle, below the umbilicus, and the block will be performed symmetrically on both sides by injecting 15 ml of ropivacaine 0.2% on each side by the attending anesthetist. will be.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplantation Hospital
Full name of responsible person
Elham Mohammadalizadeh
Street address
Sadra, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71994-67985
Phone
+98 71 3344 0000
Email
hospitalabualisina@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempour
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?