| CTRI Number |
CTRI/2021/03/032455 [Registered on: 31/03/2021] Trial Registered Prospectively |
| Last Modified On: |
31/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Placebo Controlled Trial |
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Public Title of Study
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This is a scientific work to compare the efficacy of ultrasound and peripheral nerve stimulator guided single puncture (sciatic,obturator and femoral) SOFT NERVE BLOCK vs lumbar plexus AND SCIATIC NERVE BLOCK vs combined spinal epidural for knee AND leg surgeries. |
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Scientific Title of Study
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A study to compare efficacy of USG AND PNS guided single puncture SOFT (SCIATIC,OBTURATOR, FEMORAL NERVE BLOCK TECHNIQUE)BLOCK vs lumbar plexus AND sciatic nerve block vs combined spinal epidural for knee AND leg surgeries : AN ANALYTICAL OBSERVATIONAL STUDY. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivanand Bone |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of anaesthesiology AIIMS RISHIKESH CAMPUS, Rishikesh
#418 building no.84 AIIMS, Department of anaesthesiology RISHIKESH CAMPUS
Dehradun
UTTARANCHAL
249203
India |
| Phone |
6360321907 |
| Fax |
|
| Email |
shivanandbone@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Gupta |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of anaesthesiology AIIMS RISHIKESH, Virbhadra road Rishikesh
Department of anaesthesiology AIIMS RISHIKESH, near barrage Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Bhavna Gupta |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of anaesthesiology AIIMS RISHIKESH, Virbhadra road Rishikesh
Department of anaesthesiology AIIMS RISHIKESH, Barrage road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
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Source of Monetary or Material Support
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| Department of Anaesthesiology, AIIMS RISHIKESH |
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Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NONE] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivanand Bone |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
Department of anaesthesiology, A block, level 6
Dehradun
UTTARANCHAL |
6360321907
shivanandbone@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
SOFT block vs Lumbar Sciatic vs Combined spinal epidural block |
SOFT block vs Lumbar Sciatic vs Combined spinal epidural block |
| Intervention |
USG and PNS guided SOFT block |
Using an in-plane technique a 12cm stimulating block needle will be inserted just medial to the femoral vein to a depth of 1-3cm just below and parallel to skin, then redirected towards lateral fibres of femoral nerve where 15ml of 0.5% bupivacaine will be injected. To block the obturator nerve, the probe will be moved medially placed superior to the needle and tilted cranially to identify pectineus muscle proximally. The needle will then be withdrawn to the subcutaneous tissue and redirected using an out-of-plane technique toward deep surface of pectineus where 10ml of 0.5% bupivacaine will be injected. To identify the sciatic nerve keeping the needle in situ the USG probe will be switched to a curvilinear probe, which shall be placed longitudinally just medial to the femoral vessels, inferior to the needle and rotated to or tilted to get a longitudinal image of the sciatic nerve. The needle tip will then be withdrawn to the subcutaneous plane and redirected using an in-plane technique toward sciatic nerve deep to the inferior border of quadratus femoris muscle.The needle tip will be adjusted to elicit tibial twitches using a current of 0.5-1.0 mA before injecting the drug. |
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II Category, Patients undergoing knee and leg surgeries , normal coagulation profile |
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| ExclusionCriteria |
| Details |
1. ASA grade >III
2. BMI <18 years or> 35 years
3. Patients refusing to give consent
4. Patients with coagulation abnormalities
5. Local site infection
6. History of allergy to local anaesthetics
7. Patients unable to understand or speak Hindi/ English
8. Pregnant women
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
1.To know if single puncture SOFT block can be used as
2.Alternative to CSE and lumbar plexus and sciatic nerve block for knee and leg surgeries.
3.Outcomes measured will be to study onset of sensory and motor blockade and duration of analgesia with each technique.
|
Level of sensory and motor blockade 2min, 5min, 10min, 20 min after the block
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Secondary Outcome
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| Outcome |
TimePoints |
.Effect of CSE, Lumbar plexus block and SOFT block on post op analgesia duration by VAS score
patient discomfort associated with each technique
.To Study first analgesic request time in OT
.Motor block regression time
To compare time taken to perform the procedures and the time required for onset of sensory and motor blockade.
To compare the amount of rescue analgesics required in the first 24 hrs post operatively
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Pain VAS(visual analogue scale) 1 hr , 2 hr after surgery, amount of rescue analgesics required in 24 hr, motor and sensory level level 1hr , 2hr after surgey |
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Target Sample Size
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Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
31/03/2021 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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none |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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patients undergoing knee and leg surgeries are commonly given combined spinal epidural or General anaesthesia . By giving SOFT block perioperative morbidity could be reduced. This study aims to assess the same. |