| CTRI Number |
CTRI/2023/11/059577 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two ways of numbing the nerves to see which one is better at reducing pain after a surgery for removing the womb. |
|
Scientific Title of Study
|
Comparison of quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia following total abdominal hysterectomy: A double blinded randomized 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 |
Dr Thingujam Sarjeet Singh |
| Designation |
Postgraduate Trainee |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
A block, First floor, Department of Anesthesiology Aarupadai Veedu Medical College and Hospital, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7005013267 |
| Fax |
|
| Email |
Sarjeetkhumancha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Shanmugavalli |
| Designation |
Associate professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
A block, First floor, Department of Anesthesiology, Aarupadai Veedu Medical College and Hospital, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
Vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Shanmugavalli |
| Designation |
Associate professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
A block, First floor, Department of Anesthesiology Aarupadai Veedu Medical College and Hospital, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
Vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College, Puducherry |
| Address |
Puducherry Cuddalore main road, Kirumampakkam Puducherry, India |
| Type of Sponsor |
Private medical college |
|
|
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 Shanmugavalli |
Aarupadai Veedu medical college & hospital |
First floor, A block, department of Anaesthesiology, AVMC&H, Puducherry Cuddalore main road, Kirumampakkam, Puducherry 607402
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9940882722
vallijegan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Aarupadai Veedu medical college and hospital |
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 |
| Comparator Agent |
Bupivacaine |
Injection 0.5% bupivacaine 10ml diluted to 20ml to give 0.25% bupivacaine. |
| Intervention |
Quadratus Lumborum block |
With strict aseptic precautions, under ultrasound guidance, bilateral injection of 0.25% bupivacaine (20ml on each side) at the posterior border of quadratus lumborum muscle will be given after the completion of surgery. |
| Intervention |
Tranversus Abdominis Plane Block |
With strict aseptic precautions, under ultrasound guidance, bilateral injection of 0.25% bupivacaine (20ml on each side) between the internal oblique and tranversus abdominis muscle will be injected after the completion of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female patients age 35 – 60yrs
Elective total abdominal hysterectomy under subarachnoid block
ASA class II, III
|
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA >III
Coagulopathy
Allergic to Local anesthetics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS score
Duration of first rescue analgesia
Total dose of rescue analgesics
Patient satisfaction level
|
VAS at 0hour postoperative
At 2hour postoperative
At 4hour postoperative
At 6hour postoperative
At 12hour postoperative
At 24hour postoperative
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total dose of rescue analgesics
Patient satisfaction level |
24 hours |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total abdominal hysterectomy is the most common gynaecological procedure with severe post operative pain. Various strategies are currently practiced but they have there own unwanted risk and adverse effects. So our study will be comparing two different types of nerve blocks, quadratus lumborum block and transversus abdominis plane block in patients undergoing total abdominal hysterectomy. The aim of our study will be to determine the efficacy of postoperative analgesia among the two groups. |