| CTRI Number |
CTRI/2023/08/056862 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two additive drugs to conventional local anesthesia in patients undergoing upper limb surgeries under regional anaesthesia. |
|
Scientific Title of Study
|
A randomized controlled trial to study effectiveness of nalbuphine vs dexmedetomidine as an adjuvant to local anaesthesia in patients undergoing Upper limb surgeries under ultrasound guided supraclavicular block. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITESH SINGHMAR |
| Designation |
JUNIOR RESIDENT ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE, INHS ASVINI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8867708610 |
| Fax |
|
| Email |
neeto.scorp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIDHU BHATNAGAR |
| Designation |
PROFESSOR & SENIOR ADVISOR(ANAESTHESIA) & NEUROANAESTHESIOLOGIST |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE, INHS ASVINI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9969777168 |
| Fax |
|
| Email |
vizardsvids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDHU BHATNAGAR |
| Designation |
PROFESSOR & SENIOR ADVISOR(ANAESTHESIA) & NEUROANAESTHESIOLOGIST |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE, INHS ASVINI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9969777168 |
| Fax |
|
| Email |
vizardsvids@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREINSTITUTE OF NAVAL MEDICINE INHS ASVINI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI-400005 |
| 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 VIDHU BHATNAGAR |
INHS ASVINI |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,INSTITUTE OF NAVAL MEDICINE, INHS ASVINI, COLABA , MUMBAI-400005
Mumbai
MAHARASHTRA |
9969777168
vizardsvids@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Ropivacaine, Lignocaine and Dexmedetomidine |
Group B: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml + 50 microgram dexmedetomidine diluted in 10 ml NS
Duration: Intraoperative |
| Intervention |
Ropivacaine, lignocaine and Normal Saline |
Group A: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml +10ml Normal saline (NS)
Duration: Intraoperative |
| Intervention |
Ropivacaine,lignocaine and Nalbuphine |
Group C: Receive ropivacaine plain 0.2 % 10 ml +lignocaine plain 2 % 5 ml + Nalpbuphine 10 mg diluted in 10 ml NS.
Duration: Intraoperative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II
Patient undergoing upper limb orthopaedic surgeries |
|
| ExclusionCriteria |
| Details |
1. Patients are unwilling
2. Patients with bleeding disorders,
3. Patients on anticoagulants,
4. Patients with neurological and musculoskeletal disease,
5. Infection at the site of injection
6. History of allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare:-
(a) The onset of sensory and motor blockade.
(b) The duration of sensory and motor blockade.
|
(a)Immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade
(b)In the post operative period NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraop & post op side effects & complications
|
Immediately after positioning of patient uptil the surgery is finished.
In the post operative period, Basal hemodynamics (HR, NIBP) & SpO2, requirement of rescue analgesia, nausea, vomiting will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/09/2023 |
| 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="11"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [neat.scorp@gmail.com].
- For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is randomized double blind, parallel group control trial.The selected patients will be divided into three groups of 32 patients in each group. Group A: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml +10ml Normal saline (NS), Group B: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml + 50 microgram dexmedetomidine diluted in 10 ml NS ,Group C: Receive ropivacaine plain 0.2 % 10 ml +lignocaine plain 2 % 5 ml + Nalpbuphine 10 mg diluted in 10 ml NS. On the morning of surgery computer generated randomization will be conducted and patient will be given local anaesthetic solution as per randomization. The local anaesthetic solution, with or without adjuvant, will be prepared by a different anaesthesiologist. Thus, the team giving brachial plexus block will be unaware of the local anaesthetic solution used, with or without adjuvant. Patient will also be unaware of the local anaesthetic solution, with or without adjuvant used for the block. Sensory and motor assessment will performed immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade. In the post operative period, Basal hemodynamics (HR, NIBP) and NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, nausea, vomiting will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours. Any other complications will also be noted. |