| CTRI Number |
CTRI/2024/04/065128 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy of two different anaesthetic agents in upper limb surgeries |
|
Scientific Title of Study
|
Comparative Study Of 0.5% Levobupivacaine With And Without Fentanyl In Ultrasound Guided Supraclavicular Brachial Plexus Block: A Randomised, Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smitakshi Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology,Gauhati Medical College and Hospital, Bhangagarh, Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9859787471 |
| Fax |
|
| Email |
smitakshi.das@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care,Gauhati Medical College and Hospital, Bhangagarh, Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care,Gauhati Medical College and Hospital, Bhangagarh, Guwahati
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Bhangagarh, Guwahati- 781032,Assam |
|
|
Primary Sponsor
|
| Name |
Smitakshi Das |
| Address |
Gauhati Medical College and Hospital, Bhangagarh, Guwahati |
| 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 |
| Smitakshi Das |
Orthopedic Operation Theatre, Gauhati Medical College and Hospital |
Bhangagarh,pincode- 781032 Guwahati
Kamrup
ASSAM |
9859787471
smitakshi.das@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati Medical College & Hospital |
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 |
levobupivacaine |
25ml levobupivacaine 0.5% diluted to a volume of 30ml with NS,administered via USG guided supraclavicular brachial plexus block once |
| Intervention |
levobupivacaine+fentanyl |
25ml levobupivacaine 0.5% + 1ml(50mcg) fentanyl diluted to a volume of 30ml with NS administered via USG guided supraclavicular brachial plexus block once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade 1 and 2
2. Patient posted for elective orthopaedic elbow, forearm and hand surgeries under USG guided supraclavicular brachial plexus block
3. Patients giving consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Coagulation disorders and patient on anticoagulants
2. Infection at site of injection
3. History of anaphylaxis to local anaesthetics and allergy to the study drugs
4. Patients with peripheral neuropathy.
5. Patients on chronic analgesic medications
6. Patients with contralateral phrenic nerve palsy.
7. Block failure or partial blocks
8. Pregnant and lactating patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of sensory block in each group |
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory block and motor block |
30mins |
| Duration of motor block |
till full recovery of motor function |
| Duration of analgesia |
24 hours |
| Hemodynamic changes following block |
During intraoperative period |
| Side effects and complications |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
14/04/2024 |
| 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="0"
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
|
|
Brief Summary
|
This is a prospective, double-blind, randomised control study to be conducted
in the Orthopaedic operation theatre under the Department of Anaesthesiology
and Critical care, GMCH. The study will be carried out on adult patients of
both sexes, posted for elective upper limb orthopaedic surgery. The aim of this study is to determine the efficacy of 0.5% levobupivacaine alone and 0.5%levobupivacaine
with fentanyl in USG guided supraclavicular
brachial plexus block.The primary objective is to
compare the duration of sensory block in each group. The secondary objectives are onset of sensory block, onset and duration of motor block, duration of analgesia, hemodynamic changes following block, side effects and complications. |