| 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
|
|
|
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
|
|
|
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. |