| CTRI Number |
CTRI/2025/08/092134 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between two techniques of nerve blocks used as anesthesia for foot and ankle surgeries. |
|
Scientific Title of Study
|
Ultrasound guided popliteal sciatic nerve block: A comparison of separate injections to tibial and common peroneal nerve versus injection proximal to the bifurcation. |
| 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 V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajin Arul David |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8072252136 |
| Fax |
|
| Email |
ajinarul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Type of Sponsor |
Private medical college |
|
|
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 Ajin Arul David |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU |
8072252136
ajinarul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
| Comparator Agent |
Ultrasound guided popliteal sciatic nerve block done by injection proximal to the bifurcation |
Standardized local anesthetic mixture of 20 ml 0.5% Levobupivacaine + 1ml 50mcg/ml Dexmedetomidine is prepared. Ultrasound guided popliteal sciatic nerve block is done by injecting 16ml of standardized local anesthetic mixture proximal to the bifurcation. Ultrasound guided saphenous nerve block is done be injecting 5ml of standardized local anesthetic mixture. |
| Intervention |
Ultrasound guided popliteal sciatic nerve block done by separate injections to tibial and common peroneal nerves |
Standardized local anesthetic mixture of 20 ml 0.5% Levobupivacaine + 1ml 50mcg/ml Dexmedetomidine is prepared. Ultrasound guided popliteal sciatic nerve block is done by injecting 16ml of standardized local anesthetic mixture distal to the bifurcation(8ml to each branch).
Ultrasound guided saphenous nerve block is done be injecting 5ml of standardized local anesthetic mixture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective foot or surgery
2. Age group: 18 to 60 years
3. American Society of Anesthesiologists Physical Status (ASA-PS) I, II and III
4. Both male and female patients
5. Patient providing written informed consent
|
|
| ExclusionCriteria |
| Details |
1. American Society of Anesthesiologists Physical Status (ASA-PS) IV or higher
2. Age less than 18 or more than 60 years
3. Patient refusal or inability to provide informed consent
4. Known allergy or hypersensitivity to local anesthetics
5. Infection, cellulitis, or skin lesions at the site of injection (popliteal region)
6. Pre-existing neurologic or neuromuscular disease
7. Patients with coagulopathy or on anticoagulant therapy
8. Obstetric patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the onset times and success rates of ultrasound guided popliteal sciatic nerve block done by two different techniques:
1) separate injections around tibial and common peroneal branches distal to the bifurcation, and 2) single injection around the sciatic nerve proximal to its bifurcation. |
Block progression is assessed every 3 minutes till complete blockade for onset time.
Success rate is observed at the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the block procedure time, post-operative pain & incidence of adverse events associated with ultrasound guided popliteal sciatic nerve block done by separate tibial & common peroneal branches injections compared to injecting proximal to the bifurcation. |
Block procedure time is from USG probe preparation to deposition of local anesthetic.
Post-operative pain is assessed at 2 hours, 4 hours & 8 hours post block procedure.
Adverse events are assessed immediately, 1 hour, 4 hours & 8 hours post block procedure. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, randomized clinical
study designed to compare two ultrasound-guided techniques for performing the
popliteal sciatic nerve block in patients undergoing elective foot or ankle
surgery. The primary objective is to compare the onset time and success rate of
the nerve block between the two techniques: (1) separate injections around the
tibial and common peroneal nerves distal to the bifurcation, and (2) a single
injection proximal to the bifurcation.
Secondary objectives include comparison of
the duration of blockade, postoperative pain scores, and the
incidence of adverse events.
All patients will receive a standardized
local anesthetic mixture (levobupivacaine 0.5% with dexmedetomidine), and
blocks will be administered under ultrasound guidance by experienced
anesthesiologists. Outcome assessments will be performed by a blinded observer.
The study aims to assess whether targeting
the distal nerve branches leads to a faster onset and more effective blockade,
thereby identifying the optimal technique for regional anesthesia in foot and
ankle surgeries.
|