CTRI Number |
CTRI/2019/09/021219 [Registered on: 12/09/2019] Trial Registered Prospectively |
Last Modified On: |
12/09/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
STUDY TO SEE THE EFFECT OF ERECTOR SPINAE PLANE BLOCK AND QUADRATUS LUMBORUM BLOCK FOR PAIN RELEIF IN PATIENTS UNDERGOING RENAL TRANSPLANT OPERATION |
Scientific Title of Study
|
EFFICACY OF ERECTOR SPINAE PLANE BLOCK AND QUADRATUS LUMBORUM BLOCK FOR PERIOPERATIVE ANALGESIA IN PATIENTS SCHEDULED FOR RENAL TRANSPLANTATION - A SINGLE BLINDED RANDOMIZED CONTROLLED STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr GUDELA MOHAN SAI |
Designation |
JUNIOR RESIDENT ( Postgraduate trainee) |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All India Institute of Medical Sciences
Ansari Nagar New Delhi
New Delhi DELHI 110029 India |
Phone |
9599086268 |
Fax |
|
Email |
gudelamohansai.007@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Virender Kumar Mohan |
Designation |
Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room number 5011, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
Phone |
9891557705 |
Fax |
|
Email |
dr_vkmohan@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Virender Kumar Mohan |
Designation |
Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room number 5011, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
North East DELHI 110029 India |
Phone |
9891557705 |
Fax |
|
Email |
dr_vkmohan@yahoo.com |
|
Source of Monetary or Material Support
|
Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences |
Address |
Room number 5011, Teaching block, Deparytment of Anesthesiology, Pain Medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 |
Type of Sponsor |
Research institution and hospital |
|
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 Gudela Mohan Sai |
All India Institute of Medical Sciences |
Room number 5011, Department of Anesthesiology, Pain Medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 New Delhi DELHI |
9599086268
gudelamohansai.007@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee for postgraduate research, AIIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Erector Spinae Plane Block |
30ml of 0.375% Ropivacaine injection is utilised for USG guided ipsilateral Erector spinae plane block |
Comparator Agent |
Neither Erector spinae plane block nor Quadratus lumborum block |
Patients will receive only perioperative intraoperative analgesics according to standard dosing |
Intervention |
Quadratus lumborum block |
30ml of 0.375% Ropivacaine injection is utilised for USG guided ipsilateral Quadratus lumborum block |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing renal transplantation under General Anesthesia |
|
ExclusionCriteria |
Details |
1. Patient refusal to participate
2. Known hypersensitivity to local anaesthetic drug
3. Patient having infection at site of block
4. Patient having spinal Deformity and previous history
5. Patients on anti coagulants
6. Patients with untreated psychiatric illness |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Compare perioperative fentanyl consumption between Erector spinae plane block group, Quadratus lumborum block group and control group in patients undergoing renal transplantation over a period of 24 hours after surgery |
Intraoperative time plus postoperative follow up of 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain scores using numerical rating scale, time for first rescue analgesic and incidence of postoperative nausea and vomiting between Erector spinae plane block group, Quadratus lumborum block group and control group in patients undergoing renal transplantation surgery over a period of 24 hours |
Intraoperative time plus postoperative follow up of 24 hours |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 |
Date of First Enrollment (India)
|
20/09/2019 |
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="2" Months="2" Days="2" |
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)?
|
Brief Summary
|
This study is a randomised single blinded study to compare perioperative analgesic efficacy of Erector spinae plane block and Quadratus lumborum block in patients undergoing renal transplantation |