| CTRI Number |
CTRI/2025/08/092163 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Dexmedetomidine used as an adjuvant with ropivacaine for ultrasound guided supraclavicular brachial plexus block for Upper limb surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Dexmeditomidine as an Adjuvant to 0.5% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgeries : A Randomized Double Blind Controlled Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan Swami |
| Designation |
Postgraduate student Anaesthesiolgy |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia,Maharana Bhopal Government Hospital,RNT Medical college,Udaipur
Udaipur RAJASTHAN 313001 India |
| Phone |
9991909947 |
| Fax |
|
| Email |
karanswami0099@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Karan Swami |
| Designation |
Postgraduate student Anaesthesia |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia,RNT Medical college,Udaipur Department of Anaesthesia,RNT Medical college,Udaipur Udaipur RAJASTHAN 313001 India |
| Phone |
9991909947 |
| Fax |
|
| Email |
karanswami0099@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Karan Swami |
| Designation |
Postgraduate student Anaesthesiolgy |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia,Maharana Bhopal Government Hospital,RNT Medical college,Udaipur
Udaipur RAJASTHAN 313001 India |
| Phone |
9991909947 |
| Fax |
|
| Email |
karanswami0099@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College,Udaipur |
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
RNT Medical College,Udaipur,Rajasthan,Pin code-313001 |
| 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 |
| Karan Swami |
RNT Medical College |
Department of Orthopaedics ,RNT Medical College,Near Court Circle,Udaipur,Pin Code-313001 Udaipur RAJASTHAN |
9991909947
karanswami0099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT Medical College and Controller and Attached Hospitals,Udaipur |
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 |
| Intervention |
Regional Anaesthesia |
Ultrasound Guided Supraclavicular Brachial Plexus Block |
| Comparator Agent |
Ropivacaine , Dexmeditomidine |
Ropivacaine 0.5 percent alone,Ropivacaine 0.5 percent with 50 microgram Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists physical status I-II
2.Upper limb surgeries below mid humerus level of duration 1-2 hours
3.Body Weight -40-70kgs
4.Subject Willing to Give Written and Informed Consent |
|
| ExclusionCriteria |
| Details |
1.Uncooperative Patients.
2. Infection at the site of injection.
3. History of allergy to the study drugs.
4. Bleeding disorder and coagulopathies.
5. History of convulsions, severe neurological deficits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia in the both groups. |
Duration of Analgesia is the time postoperatively when patient will demand for rescue analgesia or when patient NRS score is equal to or more then 4 in first 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Study Onset sensory block in both groups.
|
Immediately after block in minutes |
| To study onset of motor block in both groups. |
Immediately after block in minutes |
| To compare Duration of sensory in both groups. |
Assessed postoperatively in first 24 hours |
| To compare Duration of Motor block in both groups. |
Assessed Postoperatively in first 24 hours |
| To study Hemodynamic Response in both groups. |
Assessed in first 24 hours after block. |
| To study side effects and complications if any in both groups |
Assessed in first 24 hours after block. |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
11/08/2025 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The aim of giving anaesthesia to patients is performing safe and painless surgical and other medical procedures. The upper extremity peripheral nerve blocks have been extensively used by anaesthetists for upper limb surgeries for decades. The peripheral nerve blocks have several benefits like better pain control, less undesirable side effects, and reduced hospital stay over general anaesthesia, thus providing a superior outcome. In peripheral nerve blocks, injection of the regional anaesthetic is given in the close vicinity of a specific nerve or bundle of nerves to block pain sensation generated and transmitted from a specific area of the body The local anaesthetic drugs block the transmission of pain signals from surgical site to the brain. Longacting local anaesthetic agents like bupivacaine and ropivacaine have been routinely used for upper limb surgeries in supraclavicular brachial plexus block. Ropivacaine is frequently used because it produces quick, dense, and prolonged block and has lesser side effects. Due to the possibility of the effect of the local anaesthetic wearing out before the surgical period and causing severe pain, the volume of the local anaesthetic drug has been increased but it is associated with systemic side effects, particularly on the cardiovascular and nervous system. Therefore, several drugs such as opioids, nonsteroidal anti-inflammatory drugs NSAIDs, Alpha2-agonists, etc have been researched as adjunct agents to local anaesthetics. These are termed as analgesic adjuvants. They increase the efficacy and duration of local anaesthetics and decrease the systemic side effects of a higher dose of local anaesthetic. However, the adjuvant itself may exhibit its own side effects such as hypotension, sedation, bradycardia, etc. Dexmedetomidine is an Alpha 2 -adrenoreceptor agonist that has sedative, anxiolytic, and analgesic properties. Various studies have reported prolonged block and better postoperative analgesia with the administration of dexmedetomidine as an adjuvant to other local anaesthetics like bupivacaine or levobupivacaine. However, there is very limited literature available on dexmedetomidine in combination with ropivacaine and the optimal dose of dexmedetomidine as an adjuvant in nerve blocks is still to be determined. Furthermore, in clinical practice, none of the adjuvants is approved by the FDA. The use of such agents is completely off-label and depends on the assessment of risk to benefit ratio by the anaesthesiologists. Therefore, the debate regarding the advantages and disadvantages of using such an agents is a continuous topic discussion in the medical fraternity. For this reason and with this background in mind, the present study will be designed with the aim for comparative evaluation of dexmedetomidine as an adjuvant to 0.5 percent ropivacaine in supraclavicular brachial plexus block for upper limb surgeries in terms of duration of analgesia, onset and duration of sensory and motor block, quality of block, duration of postoperative analgesia |