| CTRI Number |
CTRI/2024/09/074169 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
"Comparative Efficacy of Ultrasound-Guided Popliteal Sciatic Nerve Block vs. Distal Sciatic Bifurcation Nerve Block for Below-Knee Surgeries"
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Scientific Title of Study
|
Efficacy of ultra sound guided popliteal sciatic nerve block and distal sciatic bifurcation nerve block in providing 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 |
Himaja Katamaneni |
| Designation |
JR 2 |
| Affiliation |
Shri devaraj urs medical college |
| Address |
junior resident,
department of anaesthesia,
shri devaraj urs medical college, Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
9705211527 |
| Fax |
|
| Email |
himajak67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sujatha M P |
| Designation |
professor |
| Affiliation |
Shri devaraj urs academy of higher education and research. |
| Address |
Department of anaesthesia,shri devaraj urs medical college, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9448854349 |
| Fax |
|
| Email |
drsujathamp@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sujatha M P |
| Designation |
professor |
| Affiliation |
Shri devaraj urs academy of higher education and research. |
| Address |
Department of anaesthesia, shri devaraj urs medical college, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9448854349 |
| Fax |
|
| Email |
drsujathamp@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri devaraj urs academy of higher education and research, Tamaka, Kolar, karanataka, India
563103 |
|
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Primary Sponsor
|
| Name |
Sri devaraj urs medical college |
| Address |
sri devaraj urs medical college, Tamaka, Kolar 563103 |
| Type of Sponsor |
Private medical college |
|
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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 Himaja Katamaneni |
Shri devaraj urs medical college |
Department of anaesthesia,
shri devaraj urs medical college,Tamaka,Kolar
Kolar
KARNATAKA |
9705211527
himajak67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri devaraj urs medical college |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Distal Sciatic Bifurcation Nerve Block |
Patients in group B will be given a Distal sciatic bifurcation nerve block with 0.5% Bupivacaine(30 ml). For this block also patients will be placed in prone position and the tibial nerve will be identified (lateral and superficial to popliteal artery) and will be followed anteriorly to the point where it will merge with common peroneal nerve and the bifurcation point is identified as the site where both the branches are continuous forming a bilobular pattern |
| Comparator Agent |
popliteal sciatic nerve block |
Patients in group A will be given a popliteal sciatic nerve block with 0.5% Bupivacaine(30 ml). Patient will be placed in a prone position and using a linear probe with ultra sound guidance the tibial nerve will be identified first (lateral and superficial to popliteal artery) and traced proximally to where it fuses with peroneal nerve to the point where they both form the common sciatic trunk. For this group the block performer need not be aware of the exact neural bifurcation location however for the uniformity of the block site common sciatic nerve will be traced anteriorly until its appearance changes to elliptical from circular structure. Block will be injected just distal to this level. |
| Intervention |
Popliteal Sciatic Nerve Block versus Distal Sciatic Bifurcation Nerve Block for Below-Knee Surgeries |
1 Group A: Patients in group A will be given a popliteal sciatic nerve block with 0.5% Bupivacaine(30 ml).Frequency - 1 time, and duration of intervention will be 20 mins .Patient will be placed in a prone position and using a linear probe with ultra sound guidance the tibial nerve will be identified first (lateral and superficial to popliteal artery) and traced proximally to where it fuses with peroneal nerve to the point where they both form the common sciatic trunk. For this group the block performer need not be aware of the exact neural bifurcation location however for the uniformity of the block site common sciatic nerve will be traced anteriorly until its
appearance changes to elliptical from circular structure. Block will be injected just distal to this level.
2 Group B:Patients in group B will be given a Distal sciatic bifurcation nerve block with 0.5% Bupivacaine(30 ml). Frequency - 1 time, and duration of intervention will be 20 mins . For this block also patients will be placed in prone position and the tibial nerve will be identified (lateral and superficial to popliteal artery) and will be followed anteriorly to the point where it will merge with common peroneal nerve and the bifurcation point is identified as the site where both the branches are continuous forming a bilobular pattern.
3 Intraoperatively, patient will be connected to the monitors, vitals checked, and under aseptic precautions nerve block is performed.
4 Visual analogue scale will be recorded immediately on shifting to recovery room and then at 1 hr, 4 hr, 8 hr, 12 hr, and 24 hr for both the groups. If the patient complaints of pain IV tramadol 50mg is given.
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients undergoing lower limb surgeries under regional anaesthesia.
2 ASA 1 and 2.
|
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| ExclusionCriteria |
| Details |
1 Patients with coagulation disorders.
2 Pregnant women.
3 Patients with peripheral arterial disease and peripheral neuropathies.
4 Patients not willing to participate in the study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of popliteal sciatic nerve block with distal sciatic bifurcation nerve block in terms of onset of sensory and motor blockade. |
1. Time of onset of sensory and motor blockade.
2. Time at which complete sensory and motor blockade achieved.
3. Duration of action of the block.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the duration of analgesia with popliteal sciatic nerve block & distal sciatic nerve block. |
1. Visual analogue scale postoperatively at 0 hr,1hr, 4hr , 8hr, 12hr, & 24 hr.
2. Requirement of IV analgesia within 24hrs.
3. Patient satisfaction.
|
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Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
02/10/2024 |
| 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="1"
Months="4"
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
|
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Brief Summary
|
This study aims to compare the efficacy of two ultrasound-guided techniques for sciatic nerve block in below-knee surgeries: the popliteal sciatic nerve block and the distal sciatic bifurcation nerve block. Conducted as a randomized controlled trial, the research involves adult patients scheduled for elective below-knee procedures. Participants are randomly assigned to receive either the popliteal block or the bifurcation block, with the primary outcome being the time required to achieve complete sensory and motor blockade. Secondary outcomes include the duration of analgesia, pain scores, motor function, complications, and patient satisfaction. The study seeks to determine which technique offers a faster onset and more effective anesthesia, thereby potentially improving surgical efficiency and patient comfort. |