| CTRI Number |
CTRI/2025/06/089763 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effects and safety of two spinal medicines as additive in patients having leg surgery under anaesthesia |
|
Scientific Title of Study
|
Comparison of combination of intrathecal bupivacaine fentanyl with combination of bupivacaine butarphenol for lower limb orthopaedic procedures
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd ubaidullah khan |
| Designation |
Junior resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Room number 223 new pg hostel Vilasrao Deshmukh Government Medical College gandhi chowk latur
Latur
MAHARASHTRA
413512
India |
| Phone |
8055243300 |
| Fax |
|
| Email |
Mukhan9360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh deshmukh |
| Designation |
Associate professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Torna niwas old ausa road duttakrupa society latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9561659734 |
| Fax |
|
| Email |
Apexbeat32@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohd ubaidullah khan |
| Designation |
Junior resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Department of Anaesthesia second floor surgical building vdgmc latur
Latur
MAHARASHTRA
413512
India |
| Phone |
8055243300 |
| Fax |
|
| Email |
Mukhan9360@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Vilasrao Deshmukh Government Medical College gandhi chowk latur Maharashtra 413512
India |
|
|
Primary Sponsor
|
| Name |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Gandhi chowk latur 413512
Maharashtra
India |
| 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 Mohd ubaidullah khan |
Vilasrao Deshmukh Government Medical College |
Department of Anaesthesia second floor surgical building vdgmc Near Rajasthan Marwadi School Gandhi Chowk Old Railway Station Latur 413512 Maharashtra India
Latur
MAHARASHTRA |
8055243300
Mukhan9360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vilasrao Deshmukh Government Medical College latur |
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 |
Intrathecal Bupivacaine plus Butorphanol |
0.5 percent hyperbaric bupivacaine 2.5 mL with butorphanol 250 mcg administered intrathecally in sitting position as a single dose prior to lower limb orthopedic procedures patient will be monitored intraoperatively and postoperatively for 6 hours |
| Intervention |
Intrathecal Bupivacaine plus Fentanyl |
Half percent hyperbaric bupivacaine 2 and half mL with fentanyl 15 mcg administered intrathecally in sitting position as a single dose prior to lower limb orthopedic surgery patient will be monitored intraoperatively and postoperatively for 6 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of ASA physical status 1 or 2 undergoing lower limb orthopaedic procedures |
|
| ExclusionCriteria |
| Details |
Study drugs contraindicated
Patients with neurological disease spinal deformity local skin infection or mental disorder those who were morbidly obese with impaired renal or hepatic function ASA Grade nore than 2 or history of opioid dependence |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of effective analgesia
Time from intrathecal injection to first request for rescue analgesia |
Duration of effective analgesia
Time from intrathecal injection to first request for rescue analgesia post operatively patient will be monitored every hourly for hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset time of sensory block |
At baseline upto 10 minutes after injection |
Onset time of motor block
|
At baseline upto 10 minutes after injection |
| Dermatomal level of maximum sensory blockade |
Immediately after injection utp 15–20 minutes post-injection |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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 randomized parallel group active controlled clinical trial aims to compare the efficacy and safety of two intrathecal drug combinations bupivacaine fentanyl and bupivacaine butorphanol in patients undergoing lower limb orthopedic surgeries. The primary objective is to evaluate and compare the duration of effective analgesia. Secondary objectives include comparing the onset and duration of sensory and motor block, hemodynamic changes, and incidence of adverse effects. The study hypothesizes that there may be a significant difference in analgesic profile and block characteristics between the two combinations. |