| CTRI Number |
CTRI/2025/01/079668 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of two different types of abdominal block with local anaesthetic and dexamethasone in patients undergoing hysterectomy |
|
Scientific Title of Study
|
QUADRATUS LUMBORUM BLOCK VS ERECTOR SPINAE PLANE
BLOCK FOR POSTOPERATIVE ANALGESIA USING BUPIVACAINE WITH DEXMETHASOME IN TOTAL ABDOMINAL HYSTERECTOMY PATIENTS; A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya P |
| Designation |
Assistant professor |
| Affiliation |
ACS Medical college and hospital |
| Address |
Department of Anesthesiology
A.C.S Medical college and Hospital
Vellappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
919500097995 |
| Fax |
|
| Email |
ezhil14@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwarya |
| Designation |
Assistant professor |
| Affiliation |
ACS Medical college and hospital |
| Address |
Department of Anesthesiology A.C.S Medical college and Hospital Vellappanchavadi Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
919500097995 |
| Fax |
|
| Email |
ezhil14@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya P |
| Designation |
Assistant professor |
| Affiliation |
ACS Medical college and hospital |
| Address |
Department of Anesthesiology A.C.S Medical college and Hospital Vellappanchavadi Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
919500097995 |
| Fax |
|
| Email |
ezhil14@ymail.com |
|
|
Source of Monetary or Material Support
|
| A.C.S MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
P AISHWARYA |
| Address |
A.C.S Medical college and hospital
Vellapanchavadi
Chennai -600077
India |
| 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 P AISHWARYA |
ACS MEDICAL COLLEGE AND HOSPITAL |
Department of Anesthesiology VELAPPANCHAVADI
Chennai -600077
Chennai
TAMIL NADU |
9500097995
ezhil14@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S medical college hospital |
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 |
| Comparator Agent |
QUADRATUS LUMBORUM BLOCK VERSUS ERECTOR SPINAE BLOCK |
Comparing the effectiveness of quadratus lumborum block and erector spinae block in patients undergoing total abdominal hysterectomy for post operative analgesia |
| Intervention |
Truncal blocks |
Perforforming truncal blocks in patients undergoing total abdominal hysterectomy for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status 1 & 2 |
|
| ExclusionCriteria |
| Details |
Allergy to local anaesthetics
Infection at injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time for first efficacy of erector spinae block vs Quadratus lumborum block in patients undergoing total abdominal hysterectomy |
At 2 hour,4hour,6 hour,8hour,10hour,12hour,14hour,16 hour,18hour,20hour,22hour,24hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total dose of analgesic required & severity of the postoperative pain |
2hour,4hour, 6hour, 8hour,10hour,12 hour,14hour, 16hour, 18hour, 20hour,22 hour,24hour |
|
|
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 4 |
|
Date of First Enrollment (India)
|
04/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/03/2025 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
A group of two with 30 patients each comparing the postoperative analgesics efficacy of erector spinae block versus Quadratus lumborum block using local anesthetics Bupivacaine and dexamethasone in patients undergoing total abdominal hysterectomy. |