| CTRI Number |
CTRI/2025/07/091683 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the onset and duration of block in intrathecal Dexmedetomidine versus Buprenorphine in heavy 0.5% Bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries in patient between 18 to 65 year of age |
|
Scientific Title of Study
|
Comparison of the effect of intrathecal Dexmedetomidine versus Buprenorphine as an adjuvant to Bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kachekar Aarti Suresh |
| Designation |
Junior Resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department Of Anaesthesia, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
7050099831 |
| Fax |
|
| Email |
kachekaraarti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surekha More |
| Designation |
Assistant Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department Of Anaesthesia, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9422741346 |
| Fax |
|
| Email |
desurekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kachekar Aarti Suresh |
| Designation |
Junior Resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department Of Anaesthesia, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
7050099831 |
| Fax |
|
| Email |
kachekaraarti@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia |
| Address |
Department Of Anaesthesia, Vilasrao Deshmukh Government Medical College, Latur |
| 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 Kachekar Aarti Suresh |
Government Medical College, Latur |
Orthopedic department , ward 14 and operation theatre
Latur
MAHARASHTRA |
07050099831
kachekaraarti@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 |
Inj. Buprenorphine with heavy Bupivacaine |
60 microgram of injection Buprenorphine in 3CC or 15mg of 0.5% heavy Bupivacaine in spinal anesthesia in lower limb orthopedic surgery for single surgery |
| Intervention |
Inj. Dexmedetomidine with heavy Bupivacaine |
10 microgram of injection Dexmedetomidine in 3CC or 15mg of 0.5% heavy Bupivacaine in spinal anesthesia in lower limb orthopedic surgery for single surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) grade 1 and 2 patients undergoing lower limb orthopedic surgeries. |
|
| ExclusionCriteria |
| Details |
Study drug contraindicated.
contraindication of spinal anesthesia.
spinal deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor blockade. |
2 minute , 3 minute , 5 minute , 10 minute, 15 minute , 20 minute , 30 minute, 45 minute , 1 hour , 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour, 18 hour and 24 hours after spinal anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes such as heart rate, systolic blood pressure, diastolic blood pressure , mean arterial pressure & need of post op analgesia. |
Time since induction of anesthesia, intraoperatively at interval of 5 minutes for first 20 minutes followed by every 10 minutes for next 20 min followed by 30 minutes then at 2,4,6,9,12,24 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2025 |
| 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="2"
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
|
The supplementation of local anesthetics with adjuvants
improve the efficacy of subarachnoid block.
This study was conducted to evaluate and compare
the characteristics of subarachnoid block such as sensory and motor onset and
duration , along with that the hemodynamic changes and adverse effects of
intrathecal dexmedetomidine versus buprenorphine as an adjuvant with hyperbaric
bupivacaine. |