| CTRI Number |
CTRI/2024/11/076748 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two nerve blocks for decreasing pain after surgery in patients having gallbladder removal surgery. |
|
Scientific Title of Study
|
Comparison of efficacy of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs Oblique subcostal transverse abdominis plane block (OSTAP) for postoperative pain relief in patients undergoing laparoscopic cholecystectomy. |
| 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 Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aashi Mishra |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS,
Rohtak.
Rohtak HARYANA 124001 India |
| Phone |
7906542800 |
| Fax |
|
| Email |
ashimishra97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology & Critical Care, Pt. B. D. Sharma PGIMS, Rohtak-124001, Haryana (India). |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS |
| Address |
Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana |
| 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 Jatin Lal |
Pt. B. D. Sharma PGIMS, Rohtak. |
Dept. of Anaesthesiology & Critical Care, 2nd Floor, Modular OT Complex Rohtak
Rohtak Rohtak HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics 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 |
| Intervention |
Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) |
After tracheal intubation, a high-frequency linear probe will be placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will be inserted with in-plane technique and 20 ml 0.25% bupivacaine will be injected between the transversus abdominis muscle and the lower aspect of the costal cartilage. The same procedure will be repeated on the contralateral side. |
| Comparator Agent |
Oblique subcostal transverse abdominis plane block (OSTAP) |
The patients will receive OSTAP block in the supine position immediately after the endotracheal intubation.The ultrasound with a linear probe will be placed along the subcostal margin of the upper abdominal wall and obliquely from the xiphoid to the right iliac crest in the midabdominal line. Rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin. The needle will be directed to the transversus abdominis fascia. 20 ml 0.25% bupivacaine will be injected between rectus abdominis and transversus abdominis muscles along the oblique subcostal line. The same procedure will repeated for the contralateral side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-65 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
- Refusal of consent
- Coagulation disorder.
- Infection at the injection site of the block.
- Known allergy to local anaesthetics.
- Chronic hepatic or renal failure.
- History of abdominal surgery or trauma.
- Conversion of laparoscopic to open surgery.
- Consumption of any pain killers within the 24 h before the operation.
- Chronic opioid consumption.
- Pregnancy.
- Alcohol or drug abuse.
- Body mass index (BMI) ≥ 35 kg m-2. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption. |
Postoperative 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain evaluation using Numeric Rating Scale (NRS) |
0min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively. |
| Time to first rescue analgesic |
Postoperative 24 hrs |
| Anesthetized thoracoabdominal dermatomes at 2 hours after surgery |
Postoperative 2 hrs |
| Adverse events |
Postoperative 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
25/11/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective randomised study will be conducted in 50 patients aged 18-65 years, either gender, ASA I-II undergoing elective laparoscopic cholecystectomy after obtaining institutional ethics committee approval, CTRI registration and patients written informed consent. Patient refusal of consent, coagulation disorder, infection at the injection site of the block, known allergy to local anaesthetics, chronic hepatic or renal failure, history of abdominal surgery or trauma, conversion of laparoscopic to open surgery, consumption of any pain killers within the 24 h before the operation, chronic opioid consumption, pregnancy, alcohol or drug abuse and body mass index (BMI) ≥ 35 kg m-2will be excluded. The aim of the study is to compare the efficacy of MTAPA with OSTAP block for postoperative pain relief. The primary objective is to compare the effect of M-TAPA with OSTAP blocks on post-operative rescue analgesic consumption in the first 24 hours. The secondary objectives are to assess postoperative pain evaluation using Numeric Rating Scale (NRS) at 0 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 12 hrs and 24 hrs postoperatively and at the time of rescue analgesic request, time to first rescue analgesic administration, number of thoracoabdominal dermatomes anaesthetised at 2 hrs after surgery and Adverse effects (if any). Patients will be randomized into 2 groups : Group O and Group M. Group O will be given OSTAP block bilaterally after induction of anaesthesia. Group M will be given MTAPA block bilaterally after induction of anaesthesia. Demographic data, evaluation of pain using NRS scale, time to first rescue analgesic, total rescue analgesic consumption, number of thoracoabdominal dermatomes anaesthetized and adverse effect, if any will be observed. |