| CTRI Number |
CTRI/2024/04/065381 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two techniques for post-operative pain relief after laparoscopic hernia surgery. |
|
Scientific Title of Study
|
Comparative study between ultrasound-guided Rectus sheath block and Transversus Abdominis plane block for post-operative analgesia in laparoscopic hernia surgery- a prospective randomized controlled double blinded study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinjoy Barman |
| Designation |
Post Graduate Trainee MD Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Garia, Sreenagar Main Road, Gitanjali, 1639, Kolkata
244, A.J.C. Bose Road, Bhowanipore , Kolkata-700020
Kolkata
WEST BENGAL
700094
India |
| Phone |
8240473163 |
| Fax |
|
| Email |
srinjoy.barman10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpita Laha |
| Designation |
Professor & HOD, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology, 244, Ajc Bose Road , Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433326667 |
| Fax |
|
| Email |
arpita_laha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debojyoti Das |
| Designation |
Assistant professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
C1, 2nd floor, Shiba Park,
45 Prasanna Chatterjee Road
Ghola, Sodepur
Kolkata
WEST BENGAL
700111
India |
| Phone |
9831224929 |
| Fax |
|
| Email |
dr.debojyoti12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata-700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology IPGMER and SSKM Hospital |
| Address |
Institute of Post Graduate Medical Education and Research, 244 AJC Bose Road, Kolkata-700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SRINJOY BARMAN |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Anesthesiology, 3rd floor, Main Block, Main OT Complex, General Surgery OT 1&2, 244, AJC Bose Road, kolkata -700020
Kolkata
WEST BENGAL |
8240473163
srinjoy.barman10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound-guided Rectus sheath block. |
The patients will receive US guided bilateral rectus sheath block after completion of the surgery before gaining consciousness from general anesthesia with 15ml of 0.25% bupivacaine plus dexamethasone 8mg in 5ml of normal saline to make a volume of 20ml. |
| Intervention |
Ultrasound-guided Transversus Abdominis Plane Block |
The patients will receive US guided bilateral TAP block after completion of the surgery before gaining consciousness from general anesthesia with 15 ml of 0.25% bupivacaine plus dexamethasone 8mg in 5ml of normal saline to make a volume of 20ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients that have given written, informed consent to participate in the study.
2. American society of anaesthesiologist (ASA) physical status I-II.
3. Age 18-65 years old.
4. Body mass index below 30 kg/m2
5. Patients undergoing elective laparoscopic hernia surgery |
|
| ExclusionCriteria |
| Details |
1. The chronic use of analgesics or anti inflammatory drugs
2. Allergy to local anesthetics or any of the study drugs.
3. History of co-morbidities ( MI, asthma, COPD etc)
4. Pregnancy or lactation.
5. Patients with thrombocytopenia, coagulopathies, infection at site of block.
6. Inability to communicate due to dementia, language barrier or end stage disease.
7. Refusal to participate in study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare postoperative hospital stay between groups received ultrasound guided rectus sheath block and transversus abdominis plane block. |
Post-operatively at 1,4,8,12,24 hours respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine post-operative analgesia use.
2.To determine post-operative hemodynamics.
3.To determine the incidence of adverse events. |
Post-operatively at 1,4,8,12,24 hours respectively. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this interventional study we will compare the efficacy between ultrasound guided Rectus sheath block and Transversus abdominis plane block for post operative analgesia in terms of mean duration of hospital stay, postoperative pain score, post-operative analgesic use, post-operative hemodynamics, post-operative patient satisfaction, incidence of any adverse events in anesthetized, intubated laparoscopic hernia surgery patients. |