| CTRI Number |
CTRI/2021/12/038423 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study showing effectiveness of Nalbuphine as an adjuvant to Bupivacaine in supraclavicular brachial plexus block. |
|
Scientific Title of Study
|
Comparison between Bupivacaine v/s Bupivacaine plus Nalbuphine in supraclavicular brachial plexus block: Double blind randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vatsal Shah |
| Designation |
2nd year resident, Department of Anaesthesiogy |
| Affiliation |
Govt.medical college,Bhavnagar |
| Address |
PG-1 Room 20, Sir. T Hospital Campus,
Jail Road,
Bhavnagar
H35/185 Happy Home Apt.,
Shastrinagar,
Naranpura,
Ahmedabad: 380063
Bhavnagar
GUJARAT
364001
India |
| Phone |
8160746195 |
| Fax |
|
| Email |
vats911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
Plot No.13 "MANUSMRUTI",
Opposite Shiv Park Society,
Anantwadi,
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shah |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
Plot No.13 "MANUSMRUTI",
Opposite Shiv Park Society,
Anantwadi,
Bhavnagar
Narmada
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGEBHAVNAGAR |
| Address |
Govt Medical College Bhavnagar,
Jail Road,
Bhavnagar: 364001 |
| 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 Vatsal Shah |
GOVT. MEDICAL COLLEGE and Sir. T Hospital BHAVNAGAR |
Department of Anaesthesia, GOVT. MEDICAL COLLEGE and Sir .T Hospital, BHAVNAGAR
Bhavnagar
GUJARAT |
8160746195
0278-2422011
vats911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine with normal saline group |
1 ml of Normal saline with 29 ml of inj. Bupivacaine(0.375%) given in supraclavicular brachial plexus
Frequency- single time injection
Duration 2 hrs |
| Intervention |
Inj Nalbuphine as an adjuvant to Bupivacaine in supraclavicular brachial plexus block. |
Adding 1 ml of Nalbuphine to 29 ml of bupivacaine(0.375%). Giving the injection in supraclaviclular brachial plexus.
Frequency- single time injection
Duration of therapy- 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1)American Society of Anesthesiologists (ASA) physical status I to II of either gender
2) Age: 18–58 years
3) Patients scheduled for elective forearm and hand surgeries in orthopaedic operation theaters. |
|
| ExclusionCriteria |
| Details |
1) Patients with clinically significant coagulopathy
2) Infection at the injection site
3) Allergy to local anesthetics
4) Refusal to technique
5) Patients taking psychotropic medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare effect of Inj Nalbuphine as an adjuvant to Inj Bupivacaine against Inj Bupivacaine alone in terms of
1. The onset of sensory and motor blockade.
2. Duration of sensory and motor blockade.
3. Duration of analgesia (first request for analgesic) |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hemodynamic parameters in two groups in terms of
1. Change in Blood pressure (BP).
2. Change in Respiratory rate.
3. Change in Oxygen saturation (SpO2). |
24 hrs |
|
|
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)
|
29/12/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Written informed consent will be taken in the local language. Patient will be randomized using computer generated random number sequence methods in two groups Group A- Injection Bupivacaine(0.375%)29cc +Injection Normal saline 1cc Group B-Injection Bupivacaine(0.375%)29cc +Injection Nalbuphine(10mg)1cc. After shifting the patient to the pre operative care room, 18 G intravenous catheter is inserted on non operative hand by an anaesthesia resident. Standard monitoring will be applied which includes Non invasive blood pressure(NIBP),Electrocardiographic monitoring,Heart Rate,Pulse oximeter(SPO2). Local sensitivity testing will be done. The study drug should be prepared and coded by an anaesthesiologist not involved in the study. Anaesthesiologist other than Principal investigator will perform the brachial plexus block and PI will be, responsible for monitoring of the patient. So, PI will remain blinded for the study.The onset and time to reach peak sensory & motor blockade, haemodynamic changes, regression time for sensory and motor block, duration of analgesic effect, side effect will be recorded by PI.In the operation theatre, supraclavicular block will be performed with the aid of Nerve locator (Stimuplex by B. Braun Melsungen, Germany). A 22-gauge insulated needle (Pole injector), 50 mm long, will be connected to the other pole with an alligator clamp. The plexus will be located using the supraclavicular approach. The current will be initially set to deliver 1.0 milli amperes at 2Hz stimulation frequency.End of the injection will be taken as Time ’O’. Immediately after the block, sensory and motor characteristics of blockade, hemodynamic variables, SpO2 shall be assessed by the Principal Investigator at 1,5,10,20,30 minutes and then at hourly interval till offset of sensory and motor blockade and then at four hourly interval for 24 hours. Sensory block will be assessed by pinprick test using the blunt end of a 23-gauge needle at each minute after completion of drug injection in the dermatomal areas corresponding to median nerve, ulnar nerve, radial nerve and musculocutaneous nerve till complete blockade. |