| CTRI Number |
CTRI/2025/11/097070 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effect of two pain reducing methods namely quadratus lumborum block and transversus abdominis plane block in decreasing pain in patients operated for total laparoscopic hysterectomy by comparing total dose of pain reducing drugs consumed by patients after surgery. |
|
Scientific Title of Study
|
A comparative study of Quadratus Lumborum block and Transversus Abdominis Plane block for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy-"A Prospective Randomized Controlled Trial" |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bachitar Singh |
| Designation |
DNB Anaesthesia Resident |
| Affiliation |
Livasa Hospital, Mohali |
| Address |
Department of Anaesthesia, Livasa Hospital, Mohali
Rupnagar PUNJAB 160071 India |
| Phone |
7986692323 |
| Fax |
|
| Email |
bobansandhu671@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bijay Kumar Chaurasia |
| Designation |
Consultant Anaesthesia and Intensive Care |
| Affiliation |
Livasa Hospital, Mohali |
| Address |
Department of Anaesthesia, Livasa Hospital, Mohali
PUNJAB 160071 India |
| Phone |
7986692323 |
| Fax |
|
| Email |
drbijaypgimer@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bachitar Singh |
| Designation |
DNB Anaesthesia Resident |
| Affiliation |
Livasa Hospital, Mohali |
| Address |
Department of Anaesthesia, Livasa Hospital, Mohali
PUNJAB 160071 India |
| Phone |
7986692323 |
| Fax |
|
| Email |
bobansandhu671@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Livasa Hospital |
| Address |
Livasa Hospital, Sector-71, SAS Nagar, Mohali, Punjab-160071 |
| 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 Bachitar Singh |
Livasa Hospital |
Department of Anaesthesiology, Livasa Hospital, Sector-71, SAS Nagar, Mohali, Punjab-160071 Rupnagar PUNJAB |
7986692323
bobansandhu671@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Ivy Hospital Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumborum block |
Patients operated for Total Laparoscopic Hysterectomy will be divided into two groups A and B. Group B will be administered Quadratus Lumborum block with 20 ml of 0.2 percent of Ropivacaine on both sides. |
| Comparator Agent |
Transversus Abdominis Plane block |
Patients operated for Total Laparoscopic Hysterectomy will be divided into two groups A and B. Group A will be administered Transversus Abdominis Plane block with 20 ml of 0.2 percent of Ropivacaine on both sides. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient scheduled for elective Total Laparoscopic Hysterectomy.
2. ASA physical status 1 and 2.
3. Age from 35 to 60 years.
4. Willing to give informed/written consent. |
|
| ExclusionCriteria |
| Details |
1. History of known allergy to drugs used in study.
2. Coagulopathy or patient on anticoagulant therapy.
3. ASA physical status 3 and 4.
4. Local infection.
5. BMI more than 35 kilogram per metre square.
6. Presence of psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total tramadol(analgesic) consumption in 24 hours post surgery. |
Total tramadol(analgesic) consumption in 24 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on intraoperative hemodynamics. |
|
| Intra-operative fentanyl consumption. |
|
| Pain score(VAS) 0 to 10 |
at baseline |
| Time to first analgesic in post operative period. |
|
| Post operative complications |
|
| To assess patient satisfaction scores regarding pain management in 24 hours postoperatively. |
|
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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="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
|
The study will be conducted in the operation theatre( Obstetrics and Gynaecology), Department of Anaesthesiology at Livasa Hospital, Mohali. Patients to be operated for Total Laparoscopic Hysterectomy will be enrolled. Randomization will be done into two groups A and B. Group A will be administered Transversus Abdominis Plane block. Group B will be administered Quadratus Lumborum block. Total tramadol ( analgesic) consumption in both groups will be compared to compare the analgesic efficacy of the two blocks. |