| CTRI Number |
CTRI/2021/04/032783 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
11/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to evaluate the post operative pain relief after ultrasound guided quadratus lumborum block versus transmuscular approach in laprascopic surgeries |
|
Scientific Title of Study
|
comparative Study to evaluate the post operative analgesic efficacy of ultrasound guided quadratus lumborum block :posterior versus transmuscular approach in laprascopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANGHAMITRA GHOSH |
| Designation |
fellow |
| Affiliation |
ruby hall clinic,40,sasson road,sangamwadi,pune maharashtra 411001 |
| Address |
ruby hall clinic,
40,sasson road
sangamwadi,
pune.
Maharashtra 411001
ruby hall clinic,
40,sasson road
sangamwadi,
pune.
Maharashtra 411001
Pune
MAHARASHTRA
411040
India |
| Phone |
9422193366 |
| Fax |
|
| Email |
dr.sanghamitraghosh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Dsouza |
| Designation |
Consultant |
| Affiliation |
Ruby Hall Clinic |
| Address |
40,Sasson Road, Sangamwadi,
maharashtra-411001 Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Dsouza |
| Designation |
Consultant |
| Affiliation |
Ruby Hall Clinic |
| Address |
Sasson Road, Sangamwadi, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic,40,sasson road,sangamwadi,pune,maharashtra-411001 |
|
|
Primary Sponsor
|
| Name |
ruby hall clinic |
| Address |
40,sasoon road,
sangmawadi
Pune,maharashtra411001 |
| 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 Sanghamitra Ghosh |
Department of Anaesthesia, Ruby Hall Clinic Pune |
40,Sasson road,sangamwadi pune
Pune
MAHARASHTRA |
9422193366
dr.sanghamitraghosh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R109||Unspecified abdominal pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Posterior Quadratus lumborum block versus transmuscular Quadratus lumborum block |
Ultrasound guided quadratus lumborum, interfascial plane block using 25 cc of injection ropivacaine versus transmuscular Quadratus lumborum block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willingness and giving written informed consent, ASA physical status I or II. Scheduled for laparoscopic abdominal surgery.
|
|
| ExclusionCriteria |
| Details |
Refusal to participate, Coagulopathy, Allergy to local anesthetics, Age<18 and >60yrs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Posterior QL block is better than Trasnsmuscular approach |
48 hours of pain relief |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| transmuscular quadratus lumborum block approach is better than posterior approach |
48 hours of pain relief |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/04/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
USG guided quadratus lumborum block is an effective single shot interfacial plane block which could allay post surgical pain response involving thoraco-lumbar nerves and can benefit upto 48 hours as part of multimodal analgesia in patients undergoing abldominal surgeries. |