| CTRI Number |
CTRI/2023/05/053047 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs for anaesthesia and duration of pain relief in upper limb surgeries |
|
Scientific Title of Study
|
A Comparative Study between 0.5% ropivacaine and 0.5% ropivacaine with Fentanyl in Supraclavicular Brachial Plexus Block in Upper Limb Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Agalya |
| Designation |
MBBS,MD. Senior Resident, Sardar Patel Medical College |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesia, Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
8438445611 |
| Fax |
|
| Email |
agalyaarasu9530@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Pareek |
| Designation |
MBBS, MD, Senior Professor and Former HOD, SP Medical College |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesia, Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Pareek |
| Designation |
MBBS, MD, Senior Professor and Former HOD, SP Medical College |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesia, Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.P.Medical College, Bikaner |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Associated Group of Hospitals |
| Address |
S.P.Medical College, Bikaner |
| 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 |
| T Agalya |
Sardar Patel Medical College |
Department of Anaesthesia, Room no.7, A block(I Floor), PBM Hospital
Bikaner
RAJASTHAN |
8438445611
agalyaarasu9530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Research Board of Sardar Patel Medical College , Bikaner |
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 |
0.5% Ropivacaine , Fentanyl |
26 ml of these drugs -25ml of Ropivacaine + 1ml of NS in one group and 25ml of Ropivacaine
+ 1ml of fentanyl will be given in the other group in Supraclavicular Brachial Plexus Block in patients undergoing upper limb |
| Intervention |
Supraclavicular Brachial Plexus Block |
Supraclavicular Brachial Plexus Block will be performed using the local anaesthetic agent of 26 ml (25 ml 0.5% Ropivacaine + 1ml fentanyl) which will be injected bolus, under landmark guided blind technique for the purpose of providing regional anaesthesia in patients undergoing elective upper limb surgeries and the effect of the drug will be observed 24 hours post-operatively . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I and II
Age : 18-60 years of either sex
Patients undergoing elective operative procedures for upper limb surgeries |
|
| ExclusionCriteria |
| Details |
ASA Physical Status> II
History of Bleeding diathesis
Patients on Anticoagulation therapy
Peripheral Neuropathy/Any neurologic disease/ Psychiatric diseases
Patients with known history of Respiratory diseases
History of Active Liver / Renal diseases/ Chronic Renal Impairment
Infection at the site of Block placement
Known allergy to the drugs used in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of 0.5% Ropivcaine and 0.5% Ropivacaine with fenatnyl in Supraclavicular Brachial Plexus Block in terms of -
Onset of sensory and motor block
Duration and Quality of sensory and motor block
Duration of Post operative Analgesia |
Till the drug effect is over |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the hemodynamic variables ,side effects , surgeon and patient satisfaction scores. |
24 hours post operative period |
|
|
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)
|
02/06/2023 |
| 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="1"
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
|
In order to prolong the duration of major nerve blocks, several adjuvants have been used such as epinephrine , bicarbonates, opioids, clonidine and neostigmine . There has always been search for ideal adjuvant with lesser side effects. Fentanyl , an opiod agonist, have been used in combination with bupivacaine or ropivacaine to enhance the analgesic efficacy of the drugs and also to facilitate early onset & prolongation of the block effect . There are limited studies comparing the use of ropivacaine with fentanly . Conisdering the minimal side effects and good postoperative analgesic efficacy , We made an attempt to compare the clinical characteristics of Ropivacaine with fentanyl as adjuvant in supraclavicular brachial plexus block among patients undergoing upper limb surgeries . With the primary aim to compare the efficacy of 0.5 % Ropivacaine and 0.5% Ropivacaine with fentanyl in supraclavicular Brachial Plexus Block in terms of - (1) Onset of sensory and motor block (2) Duration and Quality of sensory and motor block (3) Duration of post-operative analgesia & the secondary aim to observe the hemodynamic variables , to observe for side effects & observe surgeons and patients satisfaction . |