| CTRI Number |
CTRI/2025/07/090618 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief after after Laparoscopic surgery for Gallbladder removal: Comparison of two different method of Nerve Block |
|
Scientific Title of Study
|
Subcostal versus Posterior approach of ultrasound guided transverse abdominis plane block for postoperative analgesia following laparoscopic cholecystectomy: A Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital
East
DELHI
110095
India
East
DELHI
110095
India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital
East
DELHI
110095
India
East
DELHI
110095
India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Kumar |
| Designation |
Postgraduate student |
| Affiliation |
University College of medical sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra
East
DELHI
110095
India |
| Phone |
9973963115 |
| Fax |
|
| Email |
abhishek6333sst@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
Dilshad Garden, Shahdra
East
DELHI
110095
India |
| 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 ABHISHEK KUMAR |
University College of medical sciences and GTB Hospital |
Anaesthesia office room,2nd Floor, OT Block, Department of Anaesthesia and Critical Care, Dilshad Garden, Shahdra
East
DELHI |
09973963115
abhishek6333sst@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research (UCMS) |
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 |
Posterior TAP block |
Ultrasound guided posterior approach of TAP block will be administered at end of surgery, and prior to extubation |
| Intervention |
Subcostal TAP Block |
Ultrasound guided subcostal approach of TAP block will be administered at end of surgery, and prior to extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients aged 18-65 years of ASA status 1/2/3 scheduled for Laparoscopic cholecystectomy surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
Pregnant, obese, evidence of infection at site of injection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia (defined as time to request of first analgesic along with reported pain score of 4 or more in postoperative period after surgery). |
From end of surgery till the time when patient complains of pain after surgery, with a pain score of 4 or more. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS score for pain (0 to 10)
2. Total paracetamol dos ein 24 hours after surgery
3. Total tramadol dose in 24 hours after surgery.
|
1. NRS Score: 2 hour,6 hour, and 24 hours after surgery.
2. Total dose of paracetamol: at 24 hours after surgery.
3. Total dose of Tramadol: at 24 hour after surgery |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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 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
|
There is scanty data comparing the subcostal versus posterior approach of TAP block after laparoscopic cholecystectomy. AIM: To compare postoperative analgesic efficacy of subcostal and posterior approach of ultrasound guided TAP block following laparoscopic cholecystectomy, with dexamethasone as an adjuvant to local anaesthetics. Primary Objective: To compare the duration of analgesia (time to first postoperative analgesic request) following ultrasound guided subcostal versus posterior approach TAP block in patients undergoing laparoscopic cholecystectomy.; using levobupivacaine (0.25%, 15 ml each side) along with dexamethasone (4 mg each side) in both groups. Secondary Objective: To evaluate and compare the following in both groups: 1. NRS score (pain) at 2 hour, 6 hour, and 24 hours after surgery. 2. Total dose of paracetamol required in 24 hours after surgery. 3. Total dose of tramadol (rescue analgesic) required in 24 hours after surgery. Methodolgy: The anaesthetic management for all patients in either cohort will be standardized as per routine practice. The ultrasound-guided TAP block will be performed using a linear high frequency 6–11 MHz probe. In the subcostal-TAP block, the external oblique, internal oblique and transverse abdominis muscles will be visualized at the anterior axillary line, between the 12th rib and the iliac crest. In contrast, in the posterior-TAP block the transducer will be placed in axial plane in the midaxillary line and moved posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles. After successful extubation, patient will be shifted to post-operative ward. Postoperative multimodal analgesia will be provided using the routine technique in our institution (paracetamol 10 mg/kg i.v., every 6 hours). If at any time in the first 24 hours after surgery patient complains of pain, with a Numeric Rating Scale (NRS) score > 3, rescue analgesia will 4 be provided with tramadol (50 mg i.v.). The NRS score will be graded on a scale of 0-10, where 0 represents no pain and 10 represents the worst imaginable pain. Statistical Analysis: Statistical analysis will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Intergroup comparison of data will be done using unpaired t-test (normally distributed quantitative data), or Mann-Whitney (non-normally distributed quantitative data), or Chi-square/Fishers exact test (qualitative data). A value of p < 0.05 will be considered statistically significant. |