A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided in laparoscopic cholecystectomy
A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided in laparoscopic cholecystectomy
Design
A double-blind randomized clinical trial with parallel groups and phase 3 will be conducted on 100 patients. In one group the combination of TAP and rectus sheath blocks will be done under ultrasound guidance and in the other group the combination of the same blocks will be done under laparoscopic guidance. Randomization will be performed with the block randomization method using Random allocation software.
Settings and conduct
In this study, patients undergoing laparoscopic cholecystectomy in Imam Hossein hospital of Shahid Beheshti university of medical sciences will be enrolled. The study will be conducted as a double-blind clinical trial that the patient and outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria
In this study, 100 patients undergoing laparoscopic cholecystectomy with age between 18 to 80 years will be included. The main exclusion including drug abusers, a body mass index (BMI) higher than 30 kg/m2, having previous abdominal surgeries, and pregnancy.
Intervention groups
For patients after induction of general anesthesia, in one group the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under ultrasound guidance and in the other group the combination of the same blocks will be done under laparoscopic guidance . In the laparoscopic method, after observing the internal space through a 10 mm trocar and creating two holes with a No. 18 needle on each side of the abdominal wall, the blocks will be done using anatomical landmarks.
Main outcome variables
Duration of analgesia, dosage of analgesic drug; pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N5
Registration date:2023-08-07, 1402/05/16
Registration timing:prospective
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Nazli Karami
Name of organization / entity
Urmia University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9932
Email address
karami.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided in laparoscopic cholecystectomy
Public title
A comparative study of analgesic effect of the of the combination of transversus abdominis plane (TAP) and rectus sheath blocks between ultrasound- guided versus laparoscopic-guided
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing laparoscopic cholecystectomy
Age between 18 and 80 years
Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)
Exclusion criteria:
Drug abusers
Body mass index above 30 kg/m2
Having previous abdominal surgeries
History of psychological and neurological diseases
Pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (100 patients), 25 blocks of 4 will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the main investigator, who will assess the outcomes, will blind to patient's allocation in one of the intervention groups. Blocks will be performed by an anesthesiologist and surgeon (other than the outcome assessor). So, the list of computer-generated numbers will be given to the anesthesiologist. The physician will assign patients to groups based on computer-generated numbers. Finally, the name of groups will be label with the letters A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences., Erabi Ave., Daneshjou Blvd., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
19839693113
Approval date
2023-07-02, 1402/04/11
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.204
Health conditions studied
1
Description of health condition studied
Analgesia after laparoscopic cholecystectomy surgery
ICD-10 code
MG31.2
ICD-10 code description
Acute postoperative pain, not elsewhere classified
Primary outcomes
1
Description
Duration of analgesia
Timepoint
From the administration of the block to the administration of the first analgesic drug up to 24 hours after the surgery
Method of measurement
Minute
2
Description
Dose of analgesic drug (Morphin)
Timepoint
Up to 24 hours after the surgery
Method of measurement
Milligram
3
Description
Pain severity
Timepoint
2, 6, 12 and 24 hours after the surgery
Method of measurement
NRS scale (Numerical Rating Scale)
Secondary outcomes
1
Description
Heart rate
Timepoint
Before and 2, 6, 12 and 24 hours after the surgery
Method of measurement
Monitoring
2
Description
Systolic blood pressure
Timepoint
Before and 2, 6, 12 and 24 hours after the surgery
Method of measurement
Monitoring
3
Description
Diastolic blood pressure
Timepoint
Before and 2, 6, 12 and 24 hours after the surgery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group:In group one after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under ultrasound guidance by an anesthesiologist.
Category
Treatment - Surgery
2
Description
Intervention group: In group two after induction of general anesthesia, the combination of TAP and rectus sheath blocks with 20 cc ropivacaine 0.2% for each block (totally 40 cc) will be done under laparoscopic guidance by a surgeon.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences