| CTRI Number |
CTRI/2025/05/086227 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of USG Guided lower limb and Spinal Anaesthesia for Below Knee Surgeries. |
|
Scientific Title of Study
|
A Randomized Controlled Comparative Study of USG Guided Popliteal Sciatic Nerve Block Plus Saphenous Nerve Block and Spinal Anaesthesia for Below Knee Surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Soni |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department Of Anaesthesia , Indira Gandhi Medical college, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7618703762 |
| Fax |
|
| Email |
sonalisoni00.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Soni |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department Of Anaesthesia , Indira Gandhi Medical college, Shimla
Himachal Pradesh
171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7618703762 |
| Fax |
|
| Email |
sonalisoni00.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Soni |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Department Of Anaesthesia , Indira Gandhi Medical college, Shimla
Himachal Pradesh
171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7618703762 |
| Fax |
|
| Email |
sonalisoni00.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla , Himachal Pradesh 171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College, Shimla, Himachal Pradesh, India 171001 |
| Type of Sponsor |
Government 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 Professor Manoj Kumar Panwar |
Indira Gandhi Medical College |
Department Of Anaesthesia , Indira Gandhi Medical college, Shimla 171001
Himachal Pradesh
171009
Shimla
HIMACHAL PRADESH |
9418086876
drmanojpanwar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGMC , Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
patient will be given USG guided politeal sciatic nerve block plus saphenous nerve block |
patient will receive USG guided popliteal sciatic nerve block plus saphenous nerve block with inj bupivacaine and dexmedetomidine and patient will be assessed for 24 hours |
| Intervention |
patient will be taken under spinal anaesthesia |
patient will receive spinal anaesthesia with inj bupivacaine and dexmedetomidine and patient will be assessed for intraoperative and postoperative pain for 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing below knee surgeries who will give informed written consent to be part of study in ASAI-II. |
|
| ExclusionCriteria |
| Details |
Patients with history of allergy to local anaesthetics
Patient with history of coagulopathy or patient on anticoagulant
Patient with skin infection at site of block
Neurovascular deficit involving the lower limb
Polytrauma patients involving oher fractures, head injury
Diabetes mellitus with autonomic neuropathy
Patient with peripheral vascular disease
Pregnant woman |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of anaesthesia provided by USG guided popliteal sciatic nerve plus saphenous nerve nerve and spinal anaesthesia for below knee surgeries. |
For duration of intraoperative 90mins and postoperative 24hours , 2 hourly for 1st 6 hours and 6 hourly for remaining 18 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the postoperative pain, duration of analgesia and analgesic requirement in these patients.
To evaluate and compare the incidence of complications or side effects assciated with both techniques, including hemodynamic effects, nerve damage
to assess patient satisfaction and comfort levels with both anaesthesia technique through postoperative surveys
to compare the recovery times including the time to mobilization |
for 24 hours |
|
|
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)
|
15/05/2025 |
| 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
|
As there is limited related studies, which suggests use of popliteal sciatic nerve block plus saphenous nerve for below knee surgeries patient. This study is mainly focused on proving the efficacy of popliteal sciatic nerve block plus saphenous nerve block in below knee surgery patient is more effective than spinal anaesthesia specially in high risk patients. By giving this popliteal sciatic nerve block plus saphenous nerve block, patient will be more hemodynamically stable and less post operative pain for longer duration. There will be use of less analgesia postoperatively. |