| CTRI Number |
CTRI/2024/05/068217 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| 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 trial to study whether Buprenorphine an analgesic drug added to local anaesthetic Bupivacaine for blocking nerves supplying upper limb improves the quality of anaesthesia. |
|
Scientific Title of Study
|
“A comparative study of Ultrasound guided Supraclavicular brachial plexus block using Bupivacaine alone and the combination of Bupivacaine and Buprenorphine in patients undergoing elective upper limb orthopaedic surgeries. â€
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ZOHRA FATIMA |
| Designation |
Post graduate |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Anaesthesia department, 4th floor, 2nd division
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka India 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
7204457554 |
| Fax |
|
| Email |
zohrafatima.216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anusha Dhage |
| Designation |
Associate professor |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Anaesthesia department, 4th floor ,2nd division
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka India 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538404005 |
| Fax |
|
| Email |
Anudha.dhage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Dhage |
| Designation |
Associate professor |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Anaesthesia department, 4th floor, 2nd division
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka India 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538404005 |
| Fax |
|
| Email |
Anudha.dhage@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gulbarga institute of medical sciences
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka India 585105 |
|
|
Primary Sponsor
|
| Name |
Zohra Fatima |
| Address |
Anaesthesia department
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka India 585105 |
| 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 |
| DrZohra Fatima |
Gulbarga institute of medical sciences Hospital |
Anaesthesia department,orthopaedic operation theater major ,O.T number 1,4th floor,
New Building Gulbarga District Hospital Adjacent to SP Office, District Hospital Campus, Sedam Rd, Kalaburagi, Karnataka,India 585105
Gulbarga
KARNATAKA |
7204457554
zohrafatima.216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GULBARGA INSTITUTE OF MEDICAL SCIENCES |
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 |
Bupivacaine |
Supraclavicular brachial plexus block with 25ml of 0.25% Bupivacaine once over 5 minutes
|
| Intervention |
Combination of Bupivacaine and Buprenorphine |
Supraclavicular brachial plexus block with 25ml of 0.25% Bupivacaine and 3μg/Kg of Buprenorphine once over 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Assessed patients of ASA I and II status.
2. Both gender.
3. Normal biochemical and hematological parameters.
4. Age group between 20 -60years
5. Patients weighing 50-70 Kgs.
6. Mallampati score of I and II
7. No known neurological deficit
8. No local sepsis
|
|
| ExclusionCriteria |
| Details |
1. Patients who have not given consent.
2. Patients with anticipated difficult airway.
3. Neurological disorders
4. History of allergy to local anaesthetics
5. History of cardiovascular and respiratory disorders
6. Local bony deformities
7. History of bleeding disorders
8. Extremely obese patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of action is faster and duration of action is prolonged when Combination of Bupivacaine and Buprenorphine is used compared to Bupivacaine alone |
6 to 7 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia is prolonged when combination of Bupivacaine and Buprenorphine are used |
2to 3 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="6"
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
|
For ultrasound guided supraclavicular brachial plexus block, one group received bupivacaine alone anad other group received bupivacaine and buprenorphine. On comparing the two groups, it was found out that, Onset of sensory blockade was similar in both the groups. Onset of motor blockade was found to be earlier in bupivacaine alone group. Duration of analgesia was significantly prolonged in group that received buprenorphine compared to bupivacaine alone. The need for rescue analgesic is significantly delayed in the group that received buprenorphine compared to bupivacaine alone. There was no significant difference in the hemodynamic parameters in both the groups. There was no opioid related side effects in both the groups. No other complications were seen in both the groups. |