| CTRI Number |
CTRI/2026/04/107397 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of different adjuvants to hyperbaric Bupivacaine in subarachnoid block in lower limb orthopedic suregeries |
|
Scientific Title of Study
|
A randomized controlled trial of comparing the effects of different adjuvants to hyperbaric Bupivacaine in subarachnoid block in patients undergoing 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 Shaik Nagoor Vali |
| Designation |
Junior Resident Anaesthesiology |
| Affiliation |
7 AIR FORCE HOSPITAL |
| Address |
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Kanpur Nagar
UTTAR PRADESH
208001
India |
| Phone |
8008212019 |
| Fax |
|
| Email |
nagurvali7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wg Cdr Dr Bhaskar Das |
| Designation |
Consultant Anaesthesia |
| Affiliation |
7 AIR FORCE HOSPITAL |
| Address |
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Kanpur Nagar
UTTAR PRADESH
208001
India |
| Phone |
7507088990 |
| Fax |
|
| Email |
drbhaskar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Wg Cdr Dr Bhaskar Das |
| Designation |
Consultant Anaesthesia |
| Affiliation |
7 AIR FORCE HOSPITAL |
| Address |
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Department of Anaesthesia,
7 Air Force Hospital,Gale road, Kanpur Cantt
Kanpur Nagar
UTTAR PRADESH
208001
India |
| Phone |
7507088990 |
| Fax |
|
| Email |
drbhaskar23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Air Force Hospital |
| Address |
Gale road, Cantonment Kanpur uttar pradesh, India 208004 |
| 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 SHAIK NAGOOR VALI |
7 AIR FORCE HOSPITAL |
Department of Anaesthesia, OT complex, Gale road, cantonment kanpur
Kanpur Nagar
UTTAR PRADESH |
8008212019
nagurvali7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 7 AIR FORCE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjuvants to hyperbaric Bupivacaine |
One time addition of Dexmedetomidine to hyperbaric Bupivacaine in subarachnoid block. Effects monitored for 24 hours post spinal anaesthesia. |
| Intervention |
Adjuvants to hyperbaric Bupivacaine |
One time addition of fentanyl to hyperbaric Bupivaccaine in subarachanoid block. Effects monitored for 24 hours post spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 yrs |
|
| ExclusionCriteria |
| Details |
Infection at the site of injection
Coagulopathy or anticoagulation
Congenital anomalies of the lower spine
Any preexisting neuropathy
History of allergy to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Postoperative analgesia, block characteristics |
Outcome assessed at every 3 mins interval for first 15 mins followed by every 15 mins till completion of surgery. Hourly till regression of block in post op period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects |
Side effects assessed at every 3 mins interval for first 15 mins followed by every 15 mins till completion of surgery. Hourly till regression of block in post op period. |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
06/04/2026 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Based on current evidence, dexmedetomidine 5 µg as an intrathecal adjuvant to 0.5 hyperbaric bupivacaine offers several advantages
Faster onset of both sensory and motor blockade
Prolonged block duration and postoperative analgesia Better hemodynamic stability Minimal side effects compared to opioids like fentanyl or nalbuphine
It is a superior and safe adjuvant that enhances the quality and duration of spinal anesthesia in lower abdominal and lower limb surgeries |