| CTRI Number |
CTRI/2025/04/085739 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
patients undergoing lower limb orthopaedic surgeries will be participants divided into two groups and they will be given spinal anaesthesia with bupivacaine and nalbuphine in one group and bupivacaine and fentanyl in another group |
|
Scientific Title of Study
|
Nalbuphine versus Fentanyl as an Intrathecal Adjuvant to Hyperbaric Bupivacaine in Lower Limb Orthopaedic 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 |
Sanskruti Purohit |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences and Research |
| Address |
Depertment of Anaesthesiology
VIMSAR
BURLA
BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
8280264444 |
| Fax |
|
| Email |
doc.sp09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dulal Kishun Soren |
| Designation |
Professor and HOD, Department of Anaesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences and Research |
| Address |
Apala Hostel
VIMSAR
BURLA
BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
9437254980 |
| Fax |
|
| Email |
dulalsoren@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanskruti Purohit |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology
VIMSAR
BURLA
BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
8280264444 |
| Fax |
|
| Email |
doc.sp09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Veer Surendra Sai Institute of Medical Sciences and Research
Burla, Sambalpur
Odisha, India
Pin-768017 |
|
|
Primary Sponsor
|
| Name |
Veer Surendra Sai Institute of Medical Sciences and Research |
| Address |
Burla
Sambalpur
Odisha
India
Pin-768017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanskruti Purohit |
Veer Surendra Sai institute of Medical Sciences and research |
Burla
Sambalpur
Sambalpur
ORISSA |
8280264444
doc.sp09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Veer Surendra Sai Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal Anaesthesia |
Nalbuphine versus Fentanyl as an Intrathecal Adjuvant to Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18–60 years
Belonging to ASA Physical Status I or II
Of either sex
Undergoing elective lower limb orthopedic surgery under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients who did not give informed consent
Known hypersensitivity to any of the study drugs
Pregnancy
Coagulation disorders, spinal deformities, local infection at the puncture site, or contraindications to spinal anesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of effective postoperative analgesia provided by intrathecal Nalbuphine and Fentanyl when used as adjuvants to hyperbaric Bupivacaine in patients undergoing lower limb orthopedic surgeries.
|
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset time of sensory & motor blockade between the Nalbuphine & Fentanyl groups.
2. To assess the duration of sensory & motor blockade produced by each adjuvant.
3. To evaluate the hemodynamic stability (heart rate, blood pressure variations) intraoperatively & postoperatively in both groups.
4. To compare the incidence of adverse effects, such as nausea, vomiting, pruritus, respiratory depression, bradycardia, & hypotension. |
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)
|
20/05/2025 |
| 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
|
This trial nalbuphine versus fentanyl as an intrathecal adjuvant to hyperbaric bupivacaine in lower limb orthopaedic surgeries will be undertaken to compare the duration of anaesthesia and postoperative analgesia of both the drugs in terms of onset of sensory and motor block and duration of blocks and also compare the hemodynamic stability and incidence of adverse effects of both drugs. |