| CTRI Number |
CTRI/2022/06/043470 [Registered on: 24/06/2022] Trial Registered Prospectively |
| Last Modified On: |
23/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of Nalbuphine in prolongation of duration of post-operative analgesia when it is added as an adjuvant to 0.5%Ropivacaine in ultrasound guided supraclavicular brachial plexus blocks |
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Scientific Title of Study
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The analgesic effect of Nalbuphine as an adjuvant to 0.5% Ropivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Blocks : a prospective interventional study at SMS Hospital, Jaipur during 2021-2023.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitra Singh |
| Designation |
Associate Professor |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL, JAIPUR |
| Address |
Department of Anaesthesia, second floor, Dhanwantari Building, JAIPUR 302004 Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Singh |
| Designation |
Associate Professor |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL, JAIPUR |
| Address |
Department of Anaesthesia, second floor, Dhanwantari Building, JAIPUR 302004 Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Mathur |
| Designation |
PG Student |
| Affiliation |
SMS MEDICAL COLLEGE, JAIPUR |
| Address |
Department of Anaesthesia, second floor, Dhanwantari Building, JAIPUR 302004 Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9799920020 |
| Fax |
|
| Email |
mohitzmathur@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anaesthesia, second floor, Dhanwantari Building, SMS MEDICAL COLLEGE , JAIPUR 302004 Rajasthan |
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Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
SMS MEDICAL COLLEGE, JAIPUR 302004 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr CHITRA SINGH |
SMS MEDICAL COLLEGE AND HOSPITAL, JAIPUR |
DEPARTMENT OF ANAESTHESIA, SECOND FLOOR, DHANVANTARI BUILDING, JAIPUR 302004 RAJASTHAN
Jaipur
RAJASTHAN |
9166609479
raghuvanshichitra@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE ETHICS COMMITTEE, JAIPUR |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S52||Fracture of forearm, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
inj. Nalbuphine |
Inj. Nalbuphine 10mg(1ml) as an adjuvant to 0.5% Ropivacaine(20ml) in USG guided supraclavicular brachial plexus nerve block . After drug intervention, observation of patient will be done till request of first rescue analgesia. |
| Comparator Agent |
USG guided supraclavicular brachial plexus nerve block. |
0.5% Ropivacaine(20ml) and saline (1ml) in USG guided supraclavicular brachial plexus nerve block. After drug intervention, observation of patient will be done till request of first rescue analgesia. |
|
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.participant of fracture forearm surgeries under USG guided supraclavicular block. 2. ASA physical status class 1and 2 . 3. patients willing to participate. |
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| ExclusionCriteria |
| Details |
1. Patients with a history of allergy or hypersensitivity to either local anaesthetics or opioid group of drugs. 2. Any contra indication to peripheral nerve block. 3.impaired ability to communicate. 4.patients with raised intracranial tension. 5.pregnancy. 6.patient with coagulation disorder. 7.local infection/swelling at the site of injection. |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Duration of post-operative analgesia according to NRS scale.(time of first request of rescue analgesia). |
Every 30 minutes in first hour then every one hourly in next twelve hours. |
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Secondary Outcome
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| Outcome |
TimePoints |
| Mean duration of analgesia |
In post-operative period |
| Haemodynamic parameters |
Intraoperative period |
| Proportion of cases with complications |
Post operative period |
| Side-effects |
If any |
|
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Target Sample Size
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Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
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Date of First Enrollment (India)
|
24/06/2022 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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In this double blinded randomized controlled interventional study, we will compare the analgesic effect of nalbuphine as an adjuvant to 0.5% ropivacaine in ultrasound guided supraclavicular brachial plexus nerve blocks with the analgesic effect of 0.5% ropivacaine alone in ultrasound guided supraclavicular brachial plexus nerve blocks . |