| CTRI Number |
CTRI/2026/04/107988 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how different amounts of Nalbuphine affect pain relief when used with bupivcaine in arm surgeries |
|
Scientific Title of Study
|
Comparison of efficacy of adding doses of Nalbuphine to Bupivacaine for brachial plexus block for upper limb Surgeries A Randomised Control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subham jasiwal |
| Designation |
PGJR,Anesthesiology |
| Affiliation |
Heritage institute of medical sciences |
| Address |
Heritage institute of medical sciences, Operation theatre complex 4th floor,Bhadwar bypass,varanasi,UP 221311
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9473884884 |
| Fax |
|
| Email |
Srjneuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Gen RDS Ahluwalia retd VSM |
| Designation |
Professor(HOD),Anesthesiology |
| Affiliation |
Heritage institute of medical sciences |
| Address |
Heritage Institute of medical sciences,Dept of aneasthesiology,Room no-1,Bhadwar ,NH-2 Bypass,Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8092893751 |
| Fax |
|
| Email |
Ramandeepahluwalia@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Lt Gen RDS Ahluwalia retd VSM |
| Designation |
Professor(HOD),Anesthesiology |
| Affiliation |
Heritage institute of medical sciences |
| Address |
Heritage Institute of medical sciences,NTS Building Room No-106,Bhadwar NH-2 Bypass
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8092893751 |
| Fax |
|
| Email |
Ramandeepahluwalia@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Heritage Institute Of Medical Sciences,NH-2,Bhadwar,Varanasi,Uttar Pradesh,221311 |
|
|
Primary Sponsor
|
| Name |
Heritage Institute of Medical Sciences |
| Address |
NH-2 Bypass,Bhadwar,Varanasi,Uttar Pradesh,221311 |
| 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 Subham Jaiswal |
Heritage Institute of Medical Sciences |
Operation Theatre Complex,OT-2,4th Floor,Heritage institute of Medical Sciences,Nh-2 Bypass,bhadwar,Varanasi-221311,Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
9473884884
srjneuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nalbuphine 10 mg with Bupivacaine |
Compare efficacy of Nalbuphine 10 mg with Bupivacaine in Brachial plexus block |
| Intervention |
Nalbuphine 5 mg with Bupivacaine |
Compare efficacy of Nalbuphine 5 mg with Bupivacaine in Brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Eligible age group for study 18-65 years old of weight 50-90 kg.
Eligible gender for study Both Male and Female
ASA physical status classification I-II
Patients scheduled for elective upper limb surgery |
|
| ExclusionCriteria |
| Details |
Patients denying consent for study.
Diabetic neuropathy.
Known nerve injury in the upper limb posted for surgery.
Known contraindications to regional anaesthetic techniques as coagulopathy.
ASA physical status class III-IV.
Skin infection at site of anaesthesia.
Known hypersensitivity to the drugs used in studies.
|
|
|
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 |
| To compare the efficacy of Nalbuphine 5mg vs Nalbuphine 10mg as an adjuvant in brachial plexus block |
immediately after injection,5 Min,10 Min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess post operative duration of analgesia(using NRS score) |
immediately after surgery,At an interval of 2 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
21/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 a Double blinded Randomised control trial study compares efficacy of 5mg vs 10mg Nalbuphine(1 ml) with 0.375% bupivacaine (19 ml) for Supraclavicular brachial plexus block in upper limb surgeries,Aim of study is to assess onset of action and duration of action of both groups of patients and duration of postop analgesia |