| CTRI Number |
CTRI/2023/03/050376 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is a comparison between Levobupivacaine and Ropivacaine in PNS guided supraclavicular brachial plexus block for upper limb surgeries |
|
Scientific Title of Study
|
Comparative Study Of Levobupivacaine Vs Ropivacaine In Peripheral Nerve Stimulator Guided Supraclavicular Brachial Plexus Block For Upper Limb Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashasvini Lawania |
| Designation |
Post Graduate Resident |
| Affiliation |
PCMS AND RC, BHOPAL |
| Address |
Department Of Anaesthesia, PCMS And RC, Bhopal
Department Of Anaesthesia, PCMS And RC, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8989615497 |
| Fax |
|
| Email |
yashasvinilawania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilekh Jain |
| Designation |
Professor |
| Affiliation |
PCMS AND RC, BHOPAL |
| Address |
Department Of Anaesthesia, PCMS And RC, Bhopal
Department Of Anaesthesia, PCMS And RC, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827606268 |
| Fax |
|
| Email |
jainabhilekh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashasvini Lawania |
| Designation |
Post Graduate Resident |
| Affiliation |
PCMS AND RC, BHOPAL |
| Address |
Department Of Anaesthesia PCMS And RC Bhopal
Department Of Anaesthesia, PCMS And RC, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8989615497 |
| Fax |
|
| Email |
yashasvinilawania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College Of Medical Sciences And Research Center, Bhopal |
|
|
Primary Sponsor
|
| Name |
Dr. Yashasvini Lawania |
| Address |
Department Of Anaesthesia, PCMS And RC, Bhopal |
| Type of Sponsor |
Other [Self ] |
|
|
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 Yashasvini Lawania |
Peoples College Of Medical Sciences And Research Centre |
Department Of Anaesthesia, PCMS And RC, Bhopal
Bhopal
MADHYA PRADESH |
8989615497
yashasvinilawania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples college of medical sciences and research Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U072||COVID 19 virus not identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine |
Levobupivacaine 0.5% 20cc volume is given in upper limb surgeries in supraclavicular brachial plexus block (within the nerve sheath)with the help of peripheral nerve stimulator and observation is done for sensory and motor blockade onset and duration before the surgery and post operatively observed for need of rescue analgesia. |
| Comparator Agent |
Ropivacaine |
Ropivacaine is a long-acting amide local anaesthetic agent and first produced as a pure enantiomer. It produces effects similar to other local anaesthetics via reversible inhibition of sodium ion influx in nerve fibres. Ropivacaine 0.75% 20cc is given in upper limb surgeries in supraclavicular brachial plexus block(within the nerve sheath) with the help of perpheral nerve stimulator and observation is done for onset and duration of motor and sensory blockade onset and duration before the surgery and postoperatively observed for need of rescue analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grades 1 And 2
Scheduled for elective upper limb surgeries under supraclavicular brachial plexus block |
|
| ExclusionCriteria |
| Details |
- Patient’s refusal
- Age <18yrs and >60yrs.
- ASA grade 3 and more.
- History of serious pulmonary disease, ischemic heart disease, renal/hepaticdysfunction, coronary artery, or cervical spine disease and patients with abnormal coagulation profile.
- Patient with h/o opioid abuse.
- Patients with local skin site infections.
- Patients with hypersensitivity to any of the drugs used.
- Pregnant and lactating mothers.
- Failure of Block
- Restricted neck movement. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 0.5% Levobupivacaine vs 0.75% Ropivacaine in peripheral nerve stimulator guided supraclavicular brachial plexus block in upper limb surgeries |
For first 24 hours in 5 mins, 10 mins, 20 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effects of 0.5% Levobupivacaine vs 0.75% Ropivacaine in peripheral nerve stimulator guided supraclavicular brachial plexus block for upper limb surgeries |
First 24 hours in 5 mins, 10 mins, 15 mins, 20 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/03/2023 |
| 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="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
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
|
Various clinical trials have been done on the administration of Levobupivacaine vs Ropivacaine in neuraxial and peripheral nerve blocks for sensory and motor blockade. However, limited data is available on comparing Levobupivacaine vs Ropivacaine in brachial plexus block. Considering the low side effects and excellent postoperative analgesic efficacy of two drugs, it is essential to carry out a comparative evaluation of the two drugs. To compare the differences in Levobupivacaine and Ropivacaine for supraclavicular brachial plexus block would effect the sensory and motor blocks and duration of analgesia. The present work has been undertaken to study and compare the effect provided by Levobupivacaine vs Ropivacaine in supraclavicular brachial plexus block. |