| CTRI Number |
CTRI/2021/03/031818 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
07/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of nalbuphine and buprenorphine as adjuvants to ropivacaine in interscalene
brachial plexus block
|
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY BETWEEN NALBUPHINE AND BUPRENORPHINE AS AN AJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod CN |
| Designation |
Associate professor , Department of Anesthesiology |
| Affiliation |
Kempagowda institute of medical science |
| Address |
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9886882521 |
| Fax |
|
| Email |
drvinodcn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod CN |
| Designation |
Associate professor , Department of Anesthesiology |
| Affiliation |
Kempagowda institute of medical science |
| Address |
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9886882521 |
| Fax |
|
| Email |
drvinodcn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anitha A |
| Designation |
post graduate |
| Affiliation |
Kempagowda institute of medical science |
| Address |
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Department of Anesthesiology,
Kempagowda institute of medical science,
KR road,
v.v. puram
Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9842444924 |
| Fax |
|
| Email |
anithaads91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Anitha A
Post Graduate,
Department of Anesthesiology
Kempagowda institute of medical science,
KR road , VV puram
Bengaluru - 560004
|
|
|
Primary Sponsor
|
| Name |
Dr Anitha A |
| Address |
Post Graduate,
Department of Anesthesiology
Kempagowda institute of medical science,
KR road , VV puram
Bengaluru - 560004
|
| Type of Sponsor |
Other [Self] |
|
|
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 Anitha A |
Kempagowda Institute of medical science |
Kempagowda Institute of medical science,
KR road,
VV puram
Bangalore -560004
Bangalore
KARNATAKA |
9842444924
anithaads91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S420||Fracture of clavicle, (2) ICD-10 Condition: S424||Fracture of lower end of humerus, (3) ICD-10 Condition: S423||Fracture of shaft of humerus, (4) ICD-10 Condition: S422||Fracture of upper end of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPRENORPHINE |
AS AN AJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK |
| Intervention |
NALBUPHINE |
AS AN AJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I and
II scheduled for upper limb surgery |
|
| ExclusionCriteria |
| Details |
Any neurological deficit, peripheral neuropathies, myopathies or
chronic pain in the operative limb.
History of anaphylaxis to local anaesthetics or known allergy to any
of the study drugs to be used.
Any history of bleeding diathesis or coagulation abnormalities.
Any skin infection or local disease at the needle insertion site. BMI more than 35kg/sq-m, failure to achieve adequate block within 30 mins of administration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to onset of sensory and motor block.
Duration of sensory and motor block.
Duration of analgesia |
Time to onset of sensory and motor block.
Duration of sensory and motor block.
Duration of analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain scores
Adverse effects- Hypotension, Bradycardia,
Tachycardia, Hypoxemia, Sedation, Nausea,
Vomiting, Pruritis, Skin Rash, Dry mouth,
Dyspnea |
Pain assessed by Visual Analogue scale
Hypotension(noninvasive blood pressure less
than 20% of baseline)
Bradycardia(heart rate less than 60beats/minute)
Tachycardia(heart rate more than
100beats/minute)
Hypoxemia(oxygen saturation less than 90%)
Sedation assessed by Modified Ramsay
sedation scale
Nausea and vomiting assessed by Nausea and
vomiting scale |
|
|
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 2 |
|
Date of First Enrollment (India)
|
11/03/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the effect of Nalbuphine and Buprenorphine as an adjuvant to Ropivacaine in ultrasound guided interscalene brachial plexus block with respect to
1. To assess the onset and duration of sensory and motor blockade.
2. To assess duration of analgesia. |