| CTRI Number |
CTRI/2023/10/059354 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial to Compare of effect of different types on of regional blocks for postoperative pain relief in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of effect of subcostal transversus abdominis plane block (STAP) and Modifled thoracoabdominal nerve block through perichondrial approsch (M-TAPA) on postoperative pain and rescue analgesic requirement ni patients undergoing laparoscopic cholecystectomy: A prospective, randomised, double blind 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 |
Jyoti Sharma |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences,Bathinda’s |
| Address |
A block, IPD building, OT complex, All India institute of medical sciences,Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Sharma |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences,Bathinda’s |
| Address |
A block, IPD building, OT complex, All India institute of medical sciences,Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Sharma |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences,Bathinda’s |
| Address |
A block, IPD building, OT complex, All India institute of medical sciences,Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Bathinda |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences,bathinda |
| Address |
All India institute of medical sciences,bathinda |
| 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 |
| Jyoti Sharma |
All India institute of medical sciences,Bathinda |
Ot comlex,IPD building A Block All India Institute of Medical Sciences,Bathinda
Bathinda
PUNJAB |
9968583915
doctorjyotisharma@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bathinda Institutional 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 root block |
Modified thoracoabdominal nerve block will be performed bilaterally at the end of the surgery prior to extubation |
| Comparator Agent |
Subcostal abdominis plane block |
Subcostal transverse abdominis plane block will be performed bilaterally at the end of the surgery prior to extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 65 years of either sex with American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo Laproscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Coagulopathies
Allergic reactions to local anaesthetic • Infection at the block site
Pregnancy
History of previous abdominal surgery or trauma
Refusal to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score evaluation using static and dynamic VAS score at PACU admission, 2h, 4h, 6h and 24h postoperatively. |
2hours 4 hours 6 hours and 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total requirement of rescue analgesic consumption in the first 24h postoperative period.
2. Time to first analgesic request.
3. Adverse effects (if any) |
2hours 4 hours 6 hours and 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2023 |
| 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="0"
Months="3"
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
|
We will compare the effect of Comparison of effect of subcostal transversus abdominis plane block (STAP) and Modified thoracoabdominal nerve block through perichondrial approach (M- TAPA) on postoperative pain and rescue analgesic requirement in patients undergoing laparoscopic cholecystectomy |