| CTRI Number |
CTRI/2023/07/055203 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| 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 Ropivacaine With Dexmedetomidine Versus Magnesium Sulphate In Ultrasound Guided Supraclavicular Brachial Plexus Block For Upperlimb Surgeries. |
|
Scientific Title of Study
|
A Comparative Study To Assess The Effectiveness 0.75% Ropivacaine With Dexmedetomidine Versus 0.75% Ropivacaine With Magnesium Sulphate In Ultrasound Guided Supraclavicular Brachial Plexus Block For Upperlimb Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seetha S Prakash |
| Designation |
P G Resident |
| Affiliation |
Pushpagiri Institute Of Medical Sciences And Research Centre |
| Address |
Pushpagiri Institute Of Medical Sciences And Research Centre.
Thiruvalla
Pathanamthitta
Kerala
Department Of Anaesthesiology
Pushpagiri Institute of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
6238447283 |
| Fax |
|
| Email |
seethasp93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrReshma Balakrishnan |
| Designation |
Associate Professor |
| Affiliation |
Pushpagiri Institute Of Medical Sciences And Research Centre |
| Address |
Pushpagiri Institute Of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Department Of Anaesthesiology
Pushpagiri Institute Of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
9446816667 |
| Fax |
|
| Email |
shailender2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrReshma Balakrishnan |
| Designation |
Associate Professor |
| Affiliation |
Pushpagiri Institute Of Medical Sciences And Research Centre |
| Address |
Pushpagiri Institute Of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Department Of Anaesthesiology
Pushpagiri Institute Of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
9446816667 |
| Fax |
|
| Email |
shailender2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Pushpagiri institute of medical Sciences and research centre
Thiruvalla
Pathanamthitta
Kerala
PIN : 689101
|
|
|
Primary Sponsor
|
| Name |
Pushpagiri Institute Of Medical Sciences And Research Centre |
| Address |
Pushpagiri Institute Of Medical Sciences And Research Centre.
Thiruvalla
Kerala
Thiruvalla
Pathanamthitta
Kerala |
| Type of Sponsor |
Private 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 Seetha S Prakash |
Pushpagiri Institute Of Medical Sciences And Research Centre |
Department of Anaesthesiology Pushpagiri Institute Of Medical Sciences And Research Centre
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta
KERALA |
6238447283
seethasp93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pushpagiri institute of medical science and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and Magnesium sulphate added as adjuvants with 0.75% Ropivacaine Supraclavicular brachial plexus block for upper limb surgeries. |
This interventional study is designed to find out the better adjuvant for 0.75% Ropivacaine among Dexmedetomidine and Magnesium Sulphate to give supraclavicular brachial plexus block for upper limb surgeries.Here the comparator agents are magnesium sulphate and Dexmedetomidine.In the second group of 26 patients undergoing upper limb sugreies under supraclavicular block the block is given with 0.75% Ropivacaine 20 ml and Magnesium sulphate is added as adjuvant at a dose of 250 mg.The onset of sensory block is assessed every 1 minute by pin prick test.The onset of motor block is assessed by bromage scale.The duration of sensory block is defined as the return of sensation . The duration of motor block is defined as return of arm movement. |
| Intervention |
Dexmedetomidine and Magnesium sulphate added as adjuvants with 0.75% Ropivacaine Supraclavicular brachial plexus block for upper limb surgeries.
|
This interventional study is designed to find out the better adjuvant for 0.75% Ropivacaine among Dexmedetomidine and Magnesium Sulphate to give supraclavicular brachial plexus block for upper limb surgeries.Here the comparator agents are magnesium sulphate and Dexmedetomidine.In the first group of 26 patients undergoing upper limb sugreies under supraclavicular block the block is given with 0.75% Ropivacaine 20 ml and Dexmedetomidine is added as adjuvant at a dose of 0.5mcg/kg.The onset of sensory block is assessed every 1 minute by pin prick test.The onset of motor block is assessed by bromage scale.The duration of sensory block is defined as the return of sensation . The duration of motor block is defined as return of arm movement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing upper limb surgeries under supraclavicular brachial plexus block.Aged between 18 to 65 years and are ASA classes 1 and 2 will be included in the study after obtaining informed consent. |
|
| ExclusionCriteria |
| Details |
preexisting peripheral neuropathy .Bleeding disorders.Infection at injection site.Allergy to local anesthetics,magnesium sulphate.surgeries lasting more than 3 hours.Patients with history suggestive of arrythmias.patients who do not give consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of onset of sensory blockade.
Time of onset of motor blockade.
Duration of sensory block.
duration of motor block . |
Time of onset of sensory blockade assessed at 0 minute,1 minute,3 minutes,5minutes,7minutes,9 minutes,10 minutes likewise every 2 minutes for 20 minutes
Time of onset of motor blockade assessed at 0 minute,1 minute,3 minutes,5 minutes,7 minutes likewise every 2 minutes for 20 minutes
Duration of sensory block assessed at 4 hours,8 hours, 12 hours,16 hours,20 hours,24 hours.
duration of motor block assessed at 4 hours, 8 hours,12 hours, 16 hours , 20 hours , 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability |
monitoring of systolic blood pressure, diastolic blood pressure ,heart rate & oxygen saturation done at o hours,1hour,2hours,3hours,4hours,8hours,12hours,16hours,20hours, 24 hours after administration of supraclavicular brachial plexus block |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 4 |
|
Date of First Enrollment (India)
|
24/07/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Supraclavicular brachial plexus block is considered to be one of the most effective anaesthetic procedures for upperlimb surgeries .In this study we intend to compare the onset and duration of sensory and motor blockade obtained from the administration of 0.75% Ropivacaine with Dexmedetomidine and Magnesium sulphate as adjuvants for this block.The study is conducted in a private medical college setting in Kerala.For this study patients with distal upperlimb injuries , satisfying the inclusion criteria are randomly selected to two groups of 26 each using sealed envelope method. Then group A will be given 0.75% Ropivacaine with Dexmedetomidine and group B will be given Ropivacaine with Magnesium Sulphate.The onset of sensory block is defined as Hollman scale of 4 using pinprick.The onset of motor block is defined as achievement of Modified Bromage scale of 3.Duration of sensory block is defined as the time of block to the requirement of rescue analgesia.The duration of motor block is defined as the time of block to the arm raising above the head. |