| CTRI Number |
CTRI/2024/07/071086 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Popliteal nerve block by two techniques- Ultrasound versus peripheral nerve stimulator technique in foot and ankle surgeries |
|
Scientific Title of Study
|
Comparison of the efficacy of Ultrasound guided Popliteal nerve block versus Peripheral nerve stimulator technique for foot and ankle 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 |
Dr Ravipaul Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department Of Anaesthesiology And Intensive Care, Government Medical College, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravipaul Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesiology and Intensive care, Government medical college, Amritsar, Punjab
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravipaul Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department Of Anaesthesiology And Intensive Care, Government Medical College, Amritsar, PUNJAB
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Amritsar, Punjab |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Dev Hospital Amritsar |
| Address |
Department Of Anaesthesiology And Intensive Care, Government Medical College, Amritsar, Punjab |
| 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 Satinderjit Kaur |
Guru Nanak Dev Hospital Amritsar Punjab |
Department of Anaesthesiology and Intensive Care Government Medical College, Amritsar,Punjab
Amritsar
PUNJAB |
06280065066
drsatinder22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Popliteal block via peripheral nerve stimulator guidance |
We will give popliteal nerve block under peripheral nerve stimulator guidance and various parameters will be noted and will be compared with other groups. Total duration of intervention is from time of start of procedure to 24 hours post operative period. |
| Intervention |
Ultrasound guided Popliteal nerve block |
We will give Popliteal nerve block under Ultrasound guidance and various parameters will be noted and will be compared with groups. Total duration of intervention is from time of start of procedure to 24 hours post operative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 60 years
Both genders
Asa grade I and II
Patients with normal neurological status
Patients undergoing foot and ankle surgeries
|
|
| ExclusionCriteria |
| Details |
Refusal of patient for procedure or to enlist in surgery
Patients of asa grade III and IV
Uncooperative patients
Pregnant females
Patients with coagulation disorders and on anticoagulation therapy
Patients with history of allergy to local anaesthetics
Known neuropathies involving foot undergoing surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Procedural time (time required to complete the block)
2.Onset and grade of sensory block
3.Onset and grade of motor block
4.Success rate and adequacy of popliteal block and ratio of conversion to spinal anaesthesia
5.VAS score
|
1.Time required to complete the block
2.Sensory assessment of block at every 5 minutes interval
3.Motor assessment of the block at every 5 minutes interval
4.VAS score at 2,4,8,12,16,20,24 hours
5.Number of inadvertent vessel puncture in each block
6.Number of pricks taken in each block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic changes
2.Side effects & complications
3.Intraoperative administration of analgesics & sedatives
4.Number of inadvertent vessel puncture
5.Number of pricks taken in each block
|
1.Time from start of procedure till 24 hours post surgery |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Regional anaesthesia for lower
limb surgeries has emerged as a target oriented approach as it has minimum side-effects,
complications and is more cost effective. In lower limb surgeries popliteal
block is a good alternative to subarachnoid block as it prevents the
side-effects and complications particularly haemodynamical changes following
subarachnoid block. Popliteal block can be given via prone approach or
posterior approach. It can be performed using nerve stimulator technique or
ultrasound technique. The present study aims to compare efficacy of popliteal
block: ultrasound versus nerve stimulator technique for foot and ankle
surgeries using prone approach in patients undergoing foot and ankle surgeries
in Government medical college and hospital, Amritsar(Punjab). Patient will
receive 30ml of 0.75% of injection ropivacaine for the block. The onset of
sensory and motor block, procedure time will be assessed among the two
techniques. Haemodynamics will be assessed. Intraoperative and postoperative
complications will also be noted. |