| CTRI Number |
CTRI/2025/09/095249 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| 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 study to compare the efficacy of 0.5% bupivacaine with 30 micrograms buprenorphine and 0.5% bupivacaine with 60 micrograms buprenorphine for epidural Anaesthesia in lower limb orthopaedic surgeries on two group of participants that are exposed with this drugs . |
|
Scientific Title of Study
|
A Comparative Study of Epidural 0.5 percent Bupivacaine With 30 micrograms [mcg]Buprenorphine Versus Epidural 0.5 percent Bupivacaine With 60 micrograms [mcg]Buprenorphine For Lower Limb Orthopaedic Surgeries-Randomised Control 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 |
Yuvakeerthana R |
| Designation |
Postgraduate |
| Affiliation |
Government medical college,Ananthapuramu |
| Address |
Department of Anaesthesiology Operation theatre complex,
Government medical college,GGH, Anantapur
Anantapur
ANDHRA PRADESH
515001
India |
| Phone |
8639081222 |
| Fax |
|
| Email |
ramachandrayuvakeerthana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K.G.Sreehari |
| Designation |
MD Anaesthesiology |
| Affiliation |
Government medical college,Ananthapuramu |
| Address |
Department of Anaesthesiology Government medical college,GGH, Anantapur
Anantapur
ANDHRA PRADESH
515001
India |
| Phone |
9492495772 |
| Fax |
|
| Email |
sreeharimbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yuvakeerthana R |
| Designation |
Postgraduate |
| Affiliation |
Government medical college,Ananthapuramu |
| Address |
Department of Anaesthesiology Operation theatre complex,
Government medical college,GGH, Anantapur
ANDHRA PRADESH
515001
India |
| Phone |
8639081222 |
| Fax |
|
| Email |
ramachandrayuvakeerthana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college,Ananthapuramu |
| Address |
Government general hospital, Ananthapuramu |
| 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 |
| Yuvakeerthana R |
Government general hospital |
Department of Anaesthesiology
Operation theatre complex
Anantapur
ANDHRA PRADESH |
8639081222
ramachandrayuvakeerthana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government medical college,Ananthapuramu |
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 |
| Intervention |
Drug |
15 ml of 0.5% bupivacaine with 30 mcg of buprenorphine for epidural anaesthesia in lower limb orthopaedic surgery patients for a duration of 1 year . |
| Comparator Agent |
Drug |
15 ml of 0.5% bupivacaine with 60mcg of buprenorphine for epidural anaesthesia in lower limb orthopaedic surgery patients for a duration of 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective lower limb orthopaedic surgeries.
Patients in ASA grade 1,2,3 . |
|
| ExclusionCriteria |
| Details |
Patients with contraindications for epidural anaesthesia.
Uncooperative patients /patient refusal.
Pregnant
Patients with Spinal deformities
Patients with hypersensitivity to the study drug.
Coagulation defect /Anticoagulant therapy
Sepsis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcomes were assessed and compared in terms of time taken for the onset of sensory blockade ,motor blockade,duration of motor blockade , duration of sensory analgesia and hemodynamic changes.
|
2 weeks, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects recorded
and compared |
2 weeks,4 weeks & 8 weeks |
|
|
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)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2025 |
| 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 Yet Recruiting |
| 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 study is an attempt to compare 0.5% bupivacaine with 30 mcg buprenorphine and 0.5% bupivacaine with 60 mcg buprenorphine for epidural anaesthesia in patients scheduled for lower limb orthopaedic surgeries which alleviates severe post operative pain and decreases the need of iv opioids in post operative period. |