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CTRI Number  CTRI/2023/05/052217 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Trans-muscular quadratus lumborum block for management of post-surgical pain after gall bladder resection 
Scientific Title of Study   Trans-muscular quadratus lumborum block for post operative analgesia in laparoscopic cholecystectomy: A double blind randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Dwivedi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain and Critical Care Medicine All India Institute of Medical Sciences Gorakhpur
Department of Anaesthesia AIIMS, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Dwivedi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain and Critical Care Medicine All India Institute of Medical Sciences Gorakhpur
Department of Anaesthesia AIIMS, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Dwivedi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain and Critical Care Medicine All India Institute of Medical Sciences Gorakhpur
Department of Anaesthesia, AIIMS,Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Gorakhpur 
 
Primary Sponsor  
Name  Dr Priyanka Dwivedi 
Address  Department of Anaesthesiology, Pain and Critical Care Medicine All India Institute of Medical Sciences, Gorakhpur  
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 Priyanka Dwivedi  All India Institute of Medical Sciences, Gorakhpur  Department of Anaesthesia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH 		 8795453444

drpriyad1111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh, India-273008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1(QLB):   After completion of surgery USG guided trans-muscular quadratus lumborum block will be given using 0.3 ml/kg of 0.25% bupivacaine plain bilaterally. 
Comparator Agent  Group 2(SHAM):  After completion of surgery USG guided trans-muscular quadratus lumborum block will be given using 0.3 ml/kg of normal saline (0.9%NS) bilaterally. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for laparoscopic cholecystectomy under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. Allergies to local anesthetic drugs,
3. body mass index (BMI) >35 Kg/m,
4. Significant cardiovascular disease, hepatic dysfunction or renal dysfunction
5. Coagulation abnormalities,
6. Infection in the intended intervention site,
7. history of laparotomy
8. Inability to communicate.
9. Chronic opioid usage 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the analgesic effect of trans-muscular quadratus block after surgery in the form of visual analogue scale (VAS) score at rest.  To evaluate VAS score at 6 hours after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the analgesic effect of trans-muscular quadratus block in the form of visual analogue scale (VAS) score at rest and on coughing in 1st 24 hours
2. To compare the duration of block (The time to first analgesic request) which is defined as the time interval between end of LA injection and patients pain complaint (VAS 3).
3. To compare total analgesic consumption in 1st 24 hours.
4. To compare patient’s satisfaction
5. To compare complications if any.
 		 (VAS) score at rest and on coughing in 1st 24 hours (30 min, 1h, 2h, 4h, 6h, 8h, 12h and 24 h)  
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   18/06/2023 
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="1"
Months="1"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpriyad1111@gmail.com].

  6. For how long will this data be available start date provided 19-12-2024 and end date provided 19-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This proposed study is a prospective double blind, randomized controlled trial which will be conducted at All India Institute of Medical Sciences, Gorakhpur. In this study, we wish to investigate the effects of ultrasound-guided anterior/ trans -muscular QL block (TQLB), administered bilaterally, for post operative analgesia after laparoscopic cholecystectomy operations. Our hypothesis in this study is that patients who receive TQLB will have lower Visual Analogue Scale (VAS) values during rest and activity than the placebo group.

This trial can provide information regarding efficacy and safety of anterior/ Trans-muscular QL block (TQLB) and its role in enhance recovery after surgery (ERAS) in laparoscopic cholecystectomy.


 
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