| CTRI Number |
CTRI/2024/11/076643 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of nalbuphine and fentanyl |
|
Scientific Title of Study
|
A view of comparison of nalbuphine and fentanyl with Ropivacaine for ultrasound guided costoclavicular brachial plexus block in upper limb surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Sundaribose |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Sundari |
| Designation |
Associate Professor |
| Affiliation |
Trichy SRM Medical College Hospital and Research Centre |
| Address |
Irungalur Post, Manachanallur Taluk, Tiruchirappalli
Do
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Sundari |
| Designation |
Associate Professor |
| Affiliation |
Trichy SRM Medical College Hospital and Research Centre |
| Address |
Irungalur Post, Manachanallur Taluk, Tiruchirappalli
Do
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B Sundari |
| Designation |
Associate Professor |
| Affiliation |
Trichy SRM Medical College Hospital and Research Centre |
| Address |
Irungalur Post, Manachanallur Taluk, Tiruchirappalli
Do
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Trichy SRM Medical College Hospital and Research Centre |
| Address |
Irungalur post, Manachanallur Taluk, Tiruchirappalli |
| 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 |
| Kirubahar |
Trichy SRM Medical College Hospital and Research Centre |
Irungalur
Tiruchirappalli
TAMIL NADU |
9789369474
04312258877
rkirubahar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Trichy SRM medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj.fentanyl + Inj ropivacaine |
Inj.fentanyl 100 micrograms with inj.ropivacaine 75 mg as a single dose for nerve block preoperatively |
| Intervention |
Inj.nalbuphine + Inj ropivacaine |
Inj.nalbuphine 10 mg added to inj.ropivacaine 75 mg as single dose used for nerve block preoperatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 &2, patients posted for elective upper limb surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal , patient with systemic disease, patients allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
3 hours, 6 hours and 12 hours from the administration of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of motor block |
3 hours, 6 hours & 12 hours from the administration of block |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/12/2024 |
| 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)
|
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
|
A prospective randomised double blind study is designed to compare inj.nalbuphine as an adjuvant to Inj.ropivacaine with inj.fentanyl as an adjuvant to inj.ropivacaine in costoclavicular block. Nalbuphine is mixed kappa agonist and meu antagonist opioid. Ropivacaine is long acting local anaesthetics like Bupivacaine without cardiotoxic effects. Our aim is to compare the nalbuphine and fentanyl as an adjuvant to ropivacaine in costoclavicular block in respect to onset of sensory block, onset of motor block, , duration of sensory block, duration of motor block and total duration of analgesia. |