| CTRI Number |
CTRI/2020/10/028533 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In order to counter the postoperative pain to improve the quality of life of the patients undergoing renal surgeries,I want to compare the efficacy between the Quadratus Lumborum Block vs Epidural Block for the same. |
|
Scientific Title of Study
|
To compare the efficacy of ultrasound guided quadratus lumborum block with epidural analgesia for post operative pain management in open renal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akansha singh |
| Designation |
Junior resident |
| Affiliation |
Igmc Shimla |
| Address |
Department of anaesthesia,IGMC shimla,Himachal pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9886587917 |
| Fax |
|
| Email |
rockstar.akhi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dara Singh Negi |
| Designation |
Professor |
| Affiliation |
IGMC Shimla |
| Address |
Department of anaesthesia,IGMC shimla,Himachal pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418059643 |
| Fax |
|
| Email |
dara_negi556@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha singh |
| Designation |
Junior resident |
| Affiliation |
Igmc Shimla |
| Address |
Department of anaesthesia,IGMC shimla,Himachal pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9886587917 |
| Fax |
|
| Email |
rockstar.akhi21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia,IGMC,Shimla , Himachal Pradesh - 171001 |
|
|
Primary Sponsor
|
| Name |
Dr Akansha Singh |
| Address |
Department of anaesthesia,Igmc ,Shimla,Himachal Pradesh - 171001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department Of Anaesthesia |
IGMC ,Shimla, Himachal Pradesh - 171001 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akansha Singh |
IGMC , Shimla |
Department Of Anaesthesia
Shimla
HIMACHAL PRADESH |
9886587917
rockstar.akhi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IGMC Shimla |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N19||Unspecified kidney failure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To compare the efficacy of post operative pain relief in open renal surgeries between quadratus lumborum block and single shot epidural anesthesia |
We will compare the VAS score of the patients receiving either quadratus lumborum block or epidural anesthesia and the need for first rescue analgesic and we will also note the time taken for each procedure |
| Intervention |
To compare the efficacy of Quadratus Lumborum Block and epidural anesthesia for post operative pain in open renal surgery |
we insert epidural catheter in 1 group and give them Injection Bupivacaine 0.125% and injection Fentanyl 50 mcg total 12 ml in the epidural space through the catheter. We give a single shot Quadratus lumborum block in the other group using injection bupivacaine 0.125% and injection Fentanyl 50 mcg total 20 ml just bprior to extubation and look for the post operative pain relief efficacy among both the groups. The epidural catheter has to be left insitu for atleast 48 hrs |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing open renal surgeries
ASA physical status I and II
Height between 152-182 cm.
Weight between 40-70 kgs.
|
|
| ExclusionCriteria |
| Details |
Patient refusal for block.
Pregnant women.
Patients with known allergic reactions to local anaesthetics.
Any Contraindications for Regional Block like infection at the site of block or bleeding disorders.
5. Patients with psychiatric disorder.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare Visual Analog Score in both the groups after single shot drug injection. |
VAS score will be assessed every 30 minutes till the demand for first rescue analgesic with Injection Fenatnyl. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare the immediate hemodynamic parameters post block between both the groups.
To compare the time taken to give the block. |
1 hour |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficacy of Quadratus Lumborum Block with Epidural block for post operative pain management in open renal surgery by comparing the VAS as the primary objective of the study |