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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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