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CTRI Number  CTRI/2025/12/099618 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study on the use of a nerve block technique for reducing pain after keyhole gall bladder suregry in participants undergoing the surgery 
Scientific Title of Study   Efficacy of bilateral anterior approach quadratus lumborum block in patients undergoing laparoscopic cholecystectomy for postoperative analgesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akamksha Nair 
Designation  Post Graduate 
Affiliation  Dr B R Ambedkar Medical college and Hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura Main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8217743265  
Fax    
Email  akamksha.nair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Salim Iqbal 
Designation  Professor 
Affiliation  Dr B R Ambedkar Medical college and Hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura Main road Kadugondanahalli Bangalore


KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Akamksha Nair 
Designation  Post Graduate 
Affiliation  Dr B R Ambedkar Medical college and Hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura Main road Kadugondanahalli Bangalore


KARNATAKA
560045
India 
Phone  8217743265  
Fax    
Email  akamksha.nair@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar medical college and hospital, Kadugondanahalli, Bangalore, Karnataka, India, pin code 560045 
 
Primary Sponsor  
Name  Dr Akamksha Nair 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Bangalore Karnataka India 560045 
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 Akamksha Nair  Dr B R Ambedkar medical college and hospital  Department of Anaesthesiology 1st floor Shampura main road Kadugondanahalli Bangalore
Bangalore
KARNATAKA 
8217743265

akamksha.nair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE  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, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral anterior approach Quadratus Lumborum block   Patients posted for elective laparoscopic cholecystectomy will be given preemptive ultrasound guided bilateral anterior approach Quadratus Lumborum block using 20ml 0.2% of Inj Ropivacaine and Inj Dexamethasone 4mg, the block will take 5 minutes  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients posted for elective Laparoscopic cholecystectomy surgeries
2. Age more than 18 years and lesser than 65 years
3. American Society of Anaesthesiologists (ASA) class I,II patients 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Bleeding or coagulation abnormality
3. Local skin infection and sepsis at the site of the block
4. If laparoscopic cholecystectomy is converted into open cholecystectomy
5. known case of diabetes mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaulate the duration of analgesia in postoperative period after bilateral anterior approach Quadratus Lumborum block based on visual analogue scale   To evaulate the duration of analgesia in postoperative period after bilateral anterior approach Quadratus Lumborum block based on visual analogue scale upto 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total analgesic consumption in first 24 hours
2. Any assosciated complication due to the block (local anaesthetic toxicity, hypotension due to paravertebral spread, spread to lumbar plexus causing prolonged motor block and damage to surrounding structures like kidney or pleura) 
24 hours post administeration of block 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   12/01/2026 
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 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  

Despite advances in surgical techniques and anesthesia management, postoperative pain remains an important issue . Pain that develops after surgical intervention is multifactorial, the severity of which varies according to factors including the extent of surgical trauma, anesthesia technique, and the physiological, psychological, emotional, and sociocultural characteristics of the patient . Without timely and effective treatment, acute postoperative pain can turn into persistent chronic postoperative pain .The aim of treating post operative pain is to eliminate or at least reduce pain to a minimum level, to accelerate the healing process and to avoid side effects that can emerge with treatment.In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: Incisional pain (somatic pain) due to trocar insertion sites, Visceral pain (deep intra-abdominal pain), and Shoulder pain (presumably referred visceral pain) . Inadequate management of postoperative pain can lead to serious consequences, such as poor immediate postoperative effect, prolonged stay and/or hospital readmission, poor patient satisfaction, increased burden on patients and health systems.Multimodal analgesia technique has been widely applied in postoperative analgesia . Truncal block, including transversus abdominis plane block (TAPB), quadratus lumborum block (QLB), rectus sheath block and hernia block, play important roles in multimodal analgesia .The quadratus lumborum block (QLB) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . The local anesthetic injected via the approach of the posterior QLB (QLB type-2) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the QLB entails a broader sensory-level analgesic and may generate analgesia from T7 to L1.For laparoscopic cholecystectomy specifically, several randomized trials have investigated anterior (transmuscular) QLB. Some found significantly lower postoperative pain scores and opioid consumption with QLB, while one trial found no difference in analgesic consumption but noted reduced postoperative nausea and vomiting (PONV) . These mixed findings highlight the need for further study.Overall, the anterior QLB is an attractive adjunct for laparoscopy: it targets both somatic incisional pain and visceral input via spread to paravertebral nerves and can facilitate earlier mobilization due to its extended analgesic duration.This study aims to check the efficacy of bilateral anterior approach Quadratus lumborum block, in laparoscopic cholecystectomy patient for post operative analgesia.

 
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