| CTRI Number |
CTRI/2020/11/029435 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
27/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two methods of anaesthesia through injection given in the buttock for leg and foot surgeries |
|
Scientific Title of Study
|
A randomised comparative evaluation of ultrasound guided classical versus parasacral parallel shift (PSPS) technique of sciatic nerve block combined with femoral nerve block as a sole anaesthetic modality for orthopaedic lower limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanvir Samra |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanvir Samra |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanvir Samra |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087262379 |
| Fax |
|
| Email |
drtanvirsamra@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER Chandigarh |
Level 4, Nehru Hospital, PGIMER Chandigarh, 160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Revathi Nair |
Post-graduate Institute of Medical Education and Research Chandigarh |
Level 3, Trauma OT,ATC complex, opposite Trauma ICU, Chandigarh 160012
Chandigarh
CHANDIGARH |
8308849553
revathisnair.rn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee, PGIMER |
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 |
| Intervention |
Parasacral sciatic nerve block |
Classical approach
0.5% of 20 ml of ropivacaine
Dual ultrasound and nerve stimulator guided nerve block |
| Comparator Agent |
Parasacral sciatic nerve block |
Nil |
| Intervention |
Parasacral sciatic nerve block |
Parasacral parallel shift approach
0.5% of 20 ml of ropivacaine
Dual ultrasound and nerve stimulator guided nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing traumatic lower limb orthopaedic surgery
ASA physical status 1-3 |
|
| ExclusionCriteria |
| Details |
a) Patient refusal for nerve blocks
b) Allergy to amide local anaesthetic drugs
c) Chronic opioid therapy
d) Patients with thrombocytopenia/coagulopathy, on anti-coagulant and thrombolytic therapy
g) Morbid obesity (BMI>35 with obesity symptoms or BMI > 40)
h) Neurological diseases
i) Infections in the intervention site
j) Patients with psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare success of sciatic nerve block using classical and parasacral parallel shift approach. Successful block will be defined when both motor and sensory block is established |
30 minutes after performance of the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamic and static pain in NRS |
6hrs, 12hrs and 24hrs postoperatively
|
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Combined femoral and sciatic nerve block were initially administered for post-operative analgesia after major lower limb surgery.6 They were administered either as a single injection technique or as a continuous catheter technique.7 Various studies exist regarding the safety of combined femoral and sciatic nerve block over general and central neuraxial blocks for lower limb surgeries. 8,9.It is the primary anaesthetic modality in critically ill patients where both GA and central neuraxial block carry a high risk of mortality.10 The primary aim of this study is to compare the success of the parasacral sciatic nerve block with the classical and PSPS approach when combined with the USG femoral nerve block and administered as a sole anaesthetic agent for OLLS. The secondary aim of the study will be to compare the time to onset and intensity of sensory and motor blockade, time to first rescue analgesia and average pain scores at 6,12 and 24 hours post-operatively. |