| CTRI Number |
CTRI/2025/10/096296 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study is being done to compare two nerve block techniques for providing pain relief following laparoscopic hysterectomy. |
|
Scientific Title of Study
|
A comparative evaluation of ultrasound guided anterior quadratus lumborum block with posterior quadratus lumborum block for total laparoscopic hysterectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVESH ARORA |
| Designation |
DIRECTOR AND HOD |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT complex, 3rd floor, Department of Anesthesia, SECTOR 21 A, Badkal Flyover Road, Faridabad.
Faridabad
HARYANA
121002
India |
| Phone |
09650099113 |
| Fax |
|
| Email |
drdivesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragati Mahajan |
| Designation |
PG STUDENT |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT complex, 3rd floor, Department of Anesthesia, SECTOR 21 A, Badkal Flyover Road, Faridabad.
Faridabad
HARYANA
121002
India |
| Phone |
7006078104 |
| Fax |
|
| Email |
pragtimahajan98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIVESH ARORA |
| Designation |
DIRECTOR AND HOD |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT complex, 3rd floor, Department of Anesthesia, SECTOR 21 A, Badkal Flyover Road, Faridabad.
HARYANA
121002
India |
| Phone |
09650099113 |
| Fax |
|
| Email |
drdivesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| ASIAN INSTITUTE OF MEDICAL SCIENCES, SECTOR 21 A BADKAL FLYOVER ROAD, FARIDABAD, HARYANA |
|
|
Primary Sponsor
|
| Name |
ASIAN INSTITUTE OF MEDICAL SCIENCES |
| Address |
SECTOR 21 A, BADKAL FLYOVER ROAD, FARIDABAD-121002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DIVESH ARORA |
Asian Hospital Faridabad |
OT complex, 3rd floor, Department of Anesthesia, SECTOR 21 A, Badkal Flyover Road, Faridabad.
Faridabad
HARYANA |
09650099113
drdivesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMIITTEE |
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 |
| Intervention |
Group A (Anterior QLB):
|
Ultrasound-guided anterior quadratus lumborum block with 25 mL of 0.3% Ropivacaine + 8 mg Dexamethasone per side, administered bilaterally after induction of general anaesthesia. |
| Comparator Agent |
Group B (Posterior QLB):
|
Ultrasound-guided posterior quadratus lumborum block with 25 mL of 0.3% Ropivacaine + 8 mg Dexamethasone per side, administered bilaterally after induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged 40–65 years, belonging to ASA physical status I–II, undergoing elective total laparoscopic hysterectomy under general anaesthesia will be included for this trial. |
|
| ExclusionCriteria |
|
|
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 compare the time to first rescue analgesic requirement after anterior versus posterior quadratus lumborum block in patients undergoing total laparoscopic hysterectomy. |
0-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare total opioid consumption within 24 hours postoperatively.
To assess postoperative pain using VAS scores at defined intervals.
To evaluate side effects such as nausea, vomiting, and sedation.
To assess patient satisfaction scores. |
0,2,4,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
10/11/2025 |
| 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="0"
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
|
This prospective, randomized, double-blind, controlled clinical trial aims to compare the analgesic efficacy of two ultrasound-guided approaches of the quadratus lumborum block (QLB)—anterior and posterior—in patients undergoing total laparoscopic hysterectomy (TLH) under general anaesthesia.
A total of 56 female patients (ASA I–II, aged 40–65 years) scheduled for elective TLH will be randomly assigned into two equal groups. Group A will receive ultrasound-guided anterior QL block, while Group B will receive posterior QL block, both using 25 mL of 0.3% ropivacaine bilaterally with 8 mg dexamethasone.
Blocks will be performed post-induction by experienced anaesthesiologists. The primary outcome is the time to first rescue analgesic requirement . Secondary outcomes include total opioid consumption within 24 hours, VAS pain scores, postoperative nausea/vomiting, sedation, and patient satisfaction scores.
The study seeks to determine whether anterior QLB provides superior postoperative analgesia and greater patient satisfaction compared to the posterior approach, potentially supporting its routine use for enhanced recovery after total laparoscopic hysterectomy. |