| CTRI Number |
CTRI/2024/11/077047 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN DIFFERENT APPROACHES OF UNILATERAL QUADRATUS LUMBORUM BLOCK (LATERAL, POSTERIOR, ANTERIOR) WITH 0.5% ROPIVACAINE FOR POSTOPERATIVE ANALGESIA FOLLOWING LOWER ABDOMINAL SURGERY |
|
Scientific Title of Study
|
COMPARISON BETWEEN DIFFERENT APPROACHES OF UNILATERAL QUADRATUS LUMBORUM BLOCK WITH 0.5% ROPIVACAINE FOR POSTOPERATIVE ANALGESIA FOLLOWING LOWER ABDOMINAL 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 Shivani Pathania |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM MEDICAL COLLEGE |
| Address |
HNO 340 SANJAY ENCLAVE OPPOSITE GTK DEPOT
NEW DELHI 110033
North East
DELHI
110033
India |
| Phone |
07838704436 |
| Fax |
|
| Email |
dr.shivanipathania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C S SINGH |
| Designation |
professor |
| Affiliation |
GSVM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY GSVM MEDICAL COLLEGE LLR HOSPITAL
swaroop nagar kanpur up 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9236072730 |
| Fax |
|
| Email |
chandrashekhar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Pathania |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GSVM MEDICALCOLLEGE
LLR HOSPITAL
SWAROOP NAGAR KANPUR 208002
UTTAR PRADESH
208002
India |
| Phone |
7838704436 |
| Fax |
|
| Email |
dr.shivanipathania@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr SHIVANI PATHANIA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY GSVM MEDICAL COLLEGE |
| Type of Sponsor |
Other [] |
|
|
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 Shivani Pathania |
LLRH HOSPITAL KANPUR |
DEPARTMENT OF ANAESTHESIOLOGY
LLRH HOSPITAL GSVM MEDICAL COLLEGE KANPUR UP 208002
Kanpur Nagar
UTTAR PRADESH |
7838704436
dr.shivanipathania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EHICS COMMITTEE GSVM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIFFERENT APPROACHES OF QUADRATUS LUMBORUM BLOCK |
LATERAL POSTERIOR ANTERIOR APPROACH |
| Intervention |
quadratus lumborum block |
unilateral usg guided qudratus lumborum block is given via three approaches ie lateral posterior and anterior |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
AGE MORE THAN 18 YEARS A
ASA CLASS I AND II |
|
| ExclusionCriteria |
| Details |
relevant drug allergy, coagulation disorders, opioid dependence, sepsis
·local infection at or near the vicinity of the block site, patients with psychiatric illnesses that would interfere with perception and assessment of pain
·patients who refused to participate |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain, assessed using visual analog scale (VAS) score at 30 min, 4 hours, 6 hours, 12 hours, 24 hours postoperatively. |
Postoperative pain, assessed using visual analog scale (VAS) score at 30 min, 4 hours, 6 hours, 12 hours, 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| extent of block postoperatively at 30 min 4 hours 6hours 12 hours and 24 hours using pin prick method |
extent of block postoperatively at 30 mins 4 hours 6 hours 12 hours and 24 hours |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.shivanipathania@gmail.com].
- For how long will this data be available start date provided 05-05-2025 and end date provided 05-05-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
60 Patients, age 18 years, ASA I & II, patients were divided into three groups 20 each .lateral quadratus lumborum, posterior quadratus lumborum block and anterior quadratus lumborum block was performed unilaterally in patients under going lower abdominal surgeries were assessed for post operative pain using VAS score up to first 24 hrs of post operative period, it was observed that most of the patients who received anterior quadratus lumborum block were reported to have lower pain scores and did not required rescue analgesia than the patients who received posterior and lateral quadratus lumborum block, it was also observed that the extent of dermatomal distribution of analgesia is better in anterior quadratus lumborum block |