| CTRI Number |
CTRI/2025/07/090786 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study comparing a nerve block versus local injection for pain relief after lower abdominal surgery |
|
Scientific Title of Study
|
An Observational study to evaluate the Efficacy of ultrasound-guided quadratus Lumborum Block with Ropivacaine and Dexmedetomidine for Postoperative Analgesia in patients undergoing Open Lower Abdominal Gynaecological Surgery
|
| 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 Sudhir Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity hospital Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9971997267 |
| Fax |
|
| Email |
sudhir.kumar@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity hospital Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9971997267 |
| Fax |
|
| Email |
sudhir.kumar@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Department of Anesthesiology and Critical Care Medanta The Medicity hospital Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9971997267 |
| Fax |
|
| Email |
sudhir.kumar@medanta.org |
|
|
Source of Monetary or Material Support
|
| Medanta The Medicity Sector 38 Gurugram 122001 Haryana India |
|
|
Primary Sponsor
|
| Name |
Medanta The Medicity |
| Address |
CH Bhaktawar Singh Road Sector 38 Gurgaon Haryana 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Nidhi Agrawal |
Medanta The Medicity |
CH Bhaktawar Singh Road Sector 38 Gurgaon 122001
Gurgaon
HARYANA |
9098566720
nidhiagrawal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Quadratus Lumborum Block type 2 |
Infiltration of 0.2% Ropivaicaine 20ml each side with dexmedetomidine 1mcg/kg body weight divided bilaterally as a one time intervention lasting upto 24 hours of analgesia |
| Comparator Agent |
Local infiltration analgesia at incision site |
0.2% Ropivacaine 20ml with dexmedetomidine 1mcg/kg locally infiltrated at the incision site as one time infiltration intended to provide analgesia for 24 hours postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Adults aged 18-65 years.
Scheduled for elective open lower abdominal surgery.
ASA physical status I-II and III
|
|
| ExclusionCriteria |
| Details |
Refusal for consent
ASA IV
Patients with coagulopathies
Patients with psychological and neurological disorders
History of allergy to local anaesthetics and Tramadol.
Infection at the site of block.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the time to the first request for rescue analgesia in groups A and B |
At 30 min, 2hours , 4 hours , 8 hours , 12 hours , 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of total dose of rescue analgesic in first 24 hours after surgery |
24 hours post op |
| Comparison of the incidence of Post operative nausea and vomiting |
24 hours post op |
| Comparison of the Sedation score |
24hours post op |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
This prospective comparative study aims to evaluate the efficacy of ultrasound-guided quadratus lumborum (QL) block versus local infiltration analgesia (LIA) for postoperative pain relief in patients undergoing lower abdominal surgeries. Dexmedetomidine will be used as an adjuvant in both groups to enhance analgesic effect. The primary outcome will be postoperative pain scores assessed at defined intervals for 24 hours post-surgery. Secondary outcomes will include total analgesic consumption, duration of analgesia, and any adverse effects. This study intends to determine whether QL block provides superior analgesia compared to LIA in the early postoperative period |