| CTRI Number |
CTRI/2021/07/035211 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of pain relief between two drugs in patients undergoing surgeries on the upper limb |
|
Scientific Title of Study
|
A randomised controlled trial to compare the anaesthetic potency and hemodynamic effects of levobupivacaine+buprenorphine and bupivacaine+buprenorphine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpavathi Ture |
| Designation |
Assistant professor |
| Affiliation |
karnataka institute of medical sciences, Hubballi |
| Address |
Dr Pushpavathi Ture
Room no 206.
Department of Anaesthesiology
KIMS, Hubballi
Hubballi
Dr Pushpavathi Ture
Assistant Professor
Room number 206
Department of Anaesthesiology
KIMS Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
9448251597 |
| Fax |
|
| Email |
pushpadrture@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpavathi Ture |
| Designation |
Assistant professor |
| Affiliation |
karnataka institute of medical sciences, Hubballi |
| Address |
Dr Pushpavathi Ture
Room no 206, Department of Anaesthesiology, KIMS, Hubballi
Dr Pushpavathi Ture
Assistant Professor
Room number 206
Department of Anaesthesiology
KIMS Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
9448251597 |
| Fax |
|
| Email |
pushpadrture@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushpavathi Ture |
| Designation |
Assistant professor |
| Affiliation |
karnataka institute of medical sciences, Hubballi |
| Address |
Dr Pushpavathi Ture
Room number 206, Department of Anaesthesiology, KIMS.
Hubballi
Dr Pushpavathi Ture
Assistant Professor
Room number 206
Department of Anaesthesiology
KIMS Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
9448251597 |
| Fax |
|
| Email |
pushpadrture@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences, hubballi |
|
|
Primary Sponsor
|
| Name |
Karnataka institute of medical sciences |
| Address |
Karnataka institute of medical sciences
Vidyanagar Hubballi |
| Type of Sponsor |
Government medical college |
|
|
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 Pushpavathi Ture |
Karnataka institute of medical sciences |
Department of Anaesthesiology, Room number 206, Vidyanagar, Hubballi
Dharwad
KARNATAKA |
9448251597
pushpadrture@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S522||Fracture of shaft of ulna, (2) ICD-10 Condition: S518||Open wound of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine with buprenorphine |
Bupivacaine (0.5%) 30 ml with buprenorphine (0.3mg) to anaesthetise the upper limb with brachial plexus block using peripheral nerve stimulator for upper limb surgeries |
| Intervention |
Levobupivacaine with buprenorphine |
Levobupivacaine (0.5%) 30 ml with buprenorphine (0.3mg) to anaesthetise upper limb with brachial plexus block using peripheral nerve stimulator for surgeries on the upper limb |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-60 yrs with ASA physical status I–II who are scheduled for elective upper limb surgeries under brachial plexus block.
|
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to amide local anesthetics
2. Morbid obesity (150% the ideal weight or >130 kg).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset of sensory blockade with levobupivacaine faster than bupivacaine |
checked at baseline and then every 5 minutes for 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better hemodynamic stability in levobupivacaine group |
Blood pressure and pulse rate checked at base line and every 5 minutes for 2 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2021 |
| 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 |
|
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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Levobupivacaine the pure S(-) enantiomer of racemic bupivacaine, is a new long acting local anaesthetic that has recently been introduced in the clinical routine. Because of its significantly decreased cardiovascular and central nervous system toxicity, levobupivacaine seems to be an attractive alternative to bupivacaine. It has become a popular practice to add opioids to local anaesthetic solutions to enhance and prolong intraoperative and postoperative analgesia. However lack of comparative studies and adequate information on the anaesthetic potency of levobupivacaine with an opioid prompted us to investigate the anaesthetic potency and hemodynamic effects of bupivacaine with buprenorphine compared with levobupivacaine with buprenorphine in patients undergoing upper limb surgeries in a prospective randomized double blinded study |