| CTRI Number |
CTRI/2025/09/094503 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical comparative study of dexmedetomidine versus fentanyl versus buprenorphine as adjuvants to intrathecal bupivacaine in lower limb surgeries |
|
Scientific Title of Study
|
A clinical comparative study of dexmedetomidine , fentanyl , buprenorphine as adjuvants to intrathecal bupivacaine in lower limb 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 |
Subhajyoti konar |
| Designation |
Post graduate |
| Affiliation |
Dr. B R Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology , DR. B R Ambedkar medical college and hospital , K G Halli , bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9571835563 |
| Fax |
|
| Email |
sanjukonar10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr reshma B M |
| Designation |
Associate professor |
| Affiliation |
DR. B R Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology , DR. B R Ambedkar medical college and hospital , K G Halli , bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr reshma B M |
| Designation |
Associate professor |
| Affiliation |
DR. B R Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology , DR. B R Ambedkar medical college and hospital , K G Halli , bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R Ambedkar medical college and hospital , venkateshpuram , kadugondahalli , bengaluru , karnataka 560045 |
|
|
Primary Sponsor
|
| Name |
Dr Subhajyoti konar |
| Address |
Department of anaesthesiology , DR. B R Ambedkar medical college and hospital , K G Halli , bengaluru - 560045 |
| Type of Sponsor |
Private 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 Subhajyoti konar |
Major OT complex |
Department of anaesthesia , DR. B R Ambedkar medical college and hospital , K G halli , bengaluru - 560045
Bangalore
KARNATAKA |
9571835563
sanjukonar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M15-M19||Osteoarthritis, (3) ICD-10 Condition: M84||Disorder of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine heavy 15mg with Buprenorphine 60mcg |
Bupivacaine heavy 15mg and buprenorphine 60 mcg given in sub arachnoid block for lower limb surgeries |
| Comparator Agent |
Bupivacaine heavy 15mg with Dexmedetomidine 5mcg |
Bupivacaine heavy 15 mg and dexmedetomidine 5 mcg given in sub arachnoid block for lower limb surgeries |
| Comparator Agent |
Bupivacaine heavy 15mg with Fentanyl 25 mcg |
Bupivacaine heavy 15mg and fentanyl 25mcg given in sub arachnoid block for lower limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 60 yrs , male and female .
2. Patients of American Society of Anaesthesiologists physical status class 1 and class 2.
3. Patients scheduled for elective lower limb surgeries.
|
|
| ExclusionCriteria |
| Details |
1. BMI more than 35 kg per meter square
2. Patients with bleeding disorders or patients on anticoagulant therapy
3. Patients with history of cardiac disorders or are on beta blockers or alpha antagonists .
4. Any allergy to test drug
5. Pregnancy and lactation
6.Patients with chronic pain on slow-release preparations of opioid, drug abuse or chronic alcohol use .
7. Patients with dementia or cognitive problems.
8. Any contraindications to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To note the time duration of sensory and motor block of the intervention and 2 comparator agents |
Intraoperative and postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the adverse effects like bradycardia , hypotension , nausea , vomiting , itching , respiratory depression , desaturation |
Intraoperative |
| To assess the duration of postoperative analgesia |
Postoperative |
| To monitor heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure , oxygen saturation |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients will be selected from elective OT register . Patient will be assessed for eligibility criteria and will be randomly allocated into three groups based on computer generated randomisation. Consent will be taken and patient will be shifted inside OT . Baseline vitals will be noted and IV line will be secured . Under strict aseptic precautions , subarachnoid block will be performed with 25 gauze quincke needle in L3 to L4 interspace. Loaded drug will be given in 10 to 15 seconds after attainment of free flow of CSF . Time taken to attain sensory block till T10 and maximum sensory block attained will be noted. Motor block will be noted via Bromage scale and time taken to attain scale 3 will be noted. Intra operative vitals like heart rate , blood pressure , oxygen saturation will be assessed and any adverse effects will be treated accordingly . |