| CTRI Number |
CTRI/2024/04/064974 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
nerves blocks for pain relief after gall bladder surgery |
|
Scientific Title of Study
|
Comparison of ultrasound-guided subcostal transversus abdominis plane block and quadratus lumborum block in laparoscopic cholecystectomy: A prospective, randomized, comparative study |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Navjeet Singh |
| Designation |
Dnb resident |
| Affiliation |
Bokaro General Hospital |
| Address |
Department of Anaesthesiology, Bokaro General Hospital, Bokaro
Bokaro JHARKHAND 827004 India |
| Phone |
9650727206 |
| Fax |
|
| Email |
navsi96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi |
| Designation |
Chief Consultant |
| Affiliation |
Bokaro General Hospital |
| Address |
Department of anaesthesiology, Bokaro General Hospital, Bokaro
Bokaro JHARKHAND 827004 India |
| Phone |
8689873103 |
| Fax |
|
| Email |
Dr.nidhi2911@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi |
| Designation |
Chief Consultant |
| Affiliation |
Bokaro General Hospital |
| Address |
Department of anaesthesiology, Bokaro General Hospital, Bokaro
Bokaro JHARKHAND 827004 India |
| Phone |
8689873103 |
| Fax |
|
| Email |
Dr.nidhi2911@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Bokaro General Hospital, Bokaro, Jharkhand, India
Pin code 827004 |
|
|
Primary Sponsor
|
| Name |
Dr Navjeet Singh |
| Address |
Department of Anaesthesiology, Bokaro General Hospital, Bokaro
BOKARO
JHARKHAND
827004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Navjeet Singh |
Bokaro General Hospital |
Operation Theater room no 4
Operation Theater complex
Department of Anaesthesiology Bokaro JHARKHAND |
9650727206
navsi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICAL COMMITTEE Bokaro General Hospital |
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 quadratus lumborum block |
Usg guided quadratus lumborum block for pain relief after laparoscopic cholecystectomy
20 ml of 0.25% Bupivacaine will be given via 18 Guaze needle after skin closure
Bilaterally
will be observed at 1, 2,4,8,12,24 hours
Total duration of observation will be 24 hours post operatively |
| Intervention |
Subcostal transversus abdominis plane block |
Usg guided transversus abdominis plane block for pain relief after laparoscopic cholecystectomy
20 ml of 0.25% Bupivacaine will be given via 18 Guaze needle after skin closure
Bilaterally
will be observed at 1, 2,4,8,12,24 hours
Total duration of observation will be 24 hours post operatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I & II
2. Patient posted for elective laparoscopic Cholecystectomy
3. Patient willing to give written informed consent to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to provide consent
2. Morbid obesity
3. Local infection at site of block
4. ASA grade>2
5. History of any psychiatric illness/substance abuse/medical therapies
resulting in tolerance to opioids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score based on visual analogue scale |
post operatively after 1 hour,2 hours, 4 hours, 8 hours, 12 hours,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. need for rescue analgesia
2. side effects of the procedure |
post operatively after 1 hour,2 hours, 4 hours, 8 hours, 12 hours,24 hours |
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
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)
|
10/04/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The recent concept
of "multimodal analgesia" is a better approach that utilizes several
agents with varying modes of action on pain control pathways to reduce postoperative pain. Regional analgesia techniques like Transverse
Abdominis Plane (TAP) Block & Quadratus Lumborum (QL)Block are more
popular as they are pharmacologically safe and effective. Opioid sparing anaesthesia using blocks with a
propensity to provide better post operative analgesia than opioid based
anaesthesia which has shown to have poor patient recovery due to opioid causing
side effects. •
Very few studies has been done comparing TAP and QL block, worldwide especially
in India, we aim to compare the effectiveness of these blocks.
The
minimum sample size required for our current study is 98 patients. Randomization of the sample will be done by the computer-generated
block using random number generator to create list of random numbers. 1. GROUP A to get TAP
block using 20 mL of bupivacaine hydrochloride 0.25% (group A, n=49)
2. GROUP B to get QL block using 20 mL of
bupivacaine hydrochloride 0.25% (group B, n=49)
After skin closure, under all aseptic
and antiseptic precautions, USG guided TAP and QL Blocks will be administered
using (20ml of 0.25% Bupivacaine) following double blind technique •
The
patient will be monitored for postoperative pain by VAS Scoring at 1 hr,2hr
,4hr, 8hr, 12hr and 24 hours post operatively.
•
Patients
will also be observed for any rescue analgesia required and any side effects. |