CTRI Number |
CTRI/2023/01/048735 [Registered on: 04/01/2023] Trial Registered Prospectively |
Last Modified On: |
02/01/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two different approach to popliteal sciatic nerve block using Ultrasound |
Scientific Title of Study
|
"Comparision of ultrasound guided Posterior Approach versus Crosswise Approach to Popliteal Fossa Block for postoperative analgesia in adult patients undergoing below knee surgeries:A pilot study" |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
NIDHI SINGH |
Designation |
FELLOW IN REGIONAL ANAESTHESIA AND TRAUMA ANAESTHESIA. |
Affiliation |
GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. |
Address |
DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED
Coimbatore TAMIL NADU 641043 India |
Phone |
8861514064 |
Fax |
|
Email |
singhnidhisakarwar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
NIDHI SINGH |
Designation |
FELLOW IN REGIONAL ANAESTHESIA AND TRAUMA ANAESTHESIA. |
Affiliation |
GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. |
Address |
DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED
Coimbatore TAMIL NADU 641043 India |
Phone |
8861514064 |
Fax |
|
Email |
singhnidhisakarwar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
TUHIN MISTRY |
Designation |
JUNIOR CONSULTANT |
Affiliation |
GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. |
Address |
DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED.
Coimbatore TAMIL NADU 641043 India |
Phone |
8240823526 |
Fax |
|
Email |
dr.tuhin2014@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
GANGA HOSPITAL |
Address |
313, METTUPALAYAM ROAD, COIMBATORE
PIN-641043 |
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 |
Tuhin Mistry |
Ganga Hospital |
Department of Anaesthesiology, Ganga Hospital.
313, Mettupalayam Road, Coimbatore Coimbatore TAMIL NADU |
8240823526
dr.tuhin2014@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SCIENTIFIC REVIEW BOARD,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. |
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 |
Crosswise Approach to popliteal sciatic nerve block after surgery |
Performance of ultrasound guided Crosswise Approach to popliteal sciatic nerve block after surgery
Total duration of study 24 hours |
Intervention |
Supine posterior approach of popliteal sciatic nerve block |
Performance of ultrasound guided Supine posterior approach of popliteal sciatic nerve block after surgery
Total duration of study 24 hrs |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Pt belonging to ASA grade 1 and ASA grade 2.
Patients posted for various elective below knee surgical procedure under General Anaesthesia or regional anaesthesia.
|
|
ExclusionCriteria |
Details |
Any contraindications to popliteal sciatic block like local skin pathology, bleeding disorder, or patients on anticoagulants.
Patients not willing to participate in the study.
Patients with neurological deficit in the lower limb.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the ease of visualization of the sciatic nerve and its relation to the popliteal vessels. To compare the time taken for performing the block and duration of analgesia. |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of analgesia, Onset of sensory and motor block, Patient and anaesthesiologists satisfaction scores |
4 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
05/01/2023 |
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="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The popliteal sciatic nerve block (PSNB) is the most common practiced regional anaesthesia (RA) technique to provide anaesthesia or analgesia for foot and ankle surgery. To provide complete analgesia or anaesthesia below knee, popliteal sciatic blockade should be used together with a femoral or saphenous nerve block. The sciatic nerve can be blocked at various levels. The popliteal sciatic block can be performed using landmark-PNS guided or under ultrasound guidance. The use of ultrasound allows direct visualisation of the nerves and local anaesthetic spread with reduction in volume of local anaesthetic and hence improves the chances of successful nerve blockade. Proper positioning of the patient is the key for better visualisation of the anatomical structures. Positioning the patient may not be always possible due to various reasons such as haemodynamic instability ,painful limb movements or misalignment of non-stabilised fracture segments ,poor cooperation of patient.Hence different approaches for performing the block are studied.The main objective of this study is to compare the ultrasound guided posterior and Cross wise approach to popliteal sciatic block for surgeries involving the foot and ankle procedure in adult patients. |