| CTRI Number |
CTRI/2025/05/086347 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Between Use of local anesthetic Ropivacaine Alone and Ropivacaine with Magnesium Sulphate as adjuvant for Pain Relief Following Upper Limb Surgeries by Using a Supraclavicular Block technique |
|
Scientific Title of Study
|
To compare efficacy of ropivacaine along versus ropivacaine with magnesium sulphate for post operative analgesia in peripheral nerve stimulator guided supraclavicular plexus block in upper limb 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 |
Sikha Subhadarshini |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8457081998 |
| Fax |
|
| Email |
sikhamishra2624@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8457081998 |
| Fax |
|
| Email |
drkarunapatil78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
MAHARASHTRA
442001
India |
| Phone |
8457081998 |
| Fax |
|
| Email |
drkarunapatil78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001 |
| 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 |
| Karuna Taksande |
Acharya Vinoba Bhave Rural Hospital |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, department of anaesthesia, 2nd floor, department activity hall, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA |
8457081998
drkarunapatil78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine alone |
Ropivacaine (0.5%) administered alone for postoperative analgesia in a peripheral nerve stimulator-guided supraclavicular plexus block,for 2 years. |
| Intervention |
Ropivacaine with Magnesium Sulphate |
Ropivacaine (0.5%) combined with Magnesium Sulphate (50 mg) administered for postoperative analgesia in a peripheral nerve stimulator-guided supraclavicular plexus block for 2years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing upper limb surgeries requiring supraclavicular plexus block. American Society of Anesthesiologists (ASA) Physical Status I and II.
Willing to provide written informed consent. Body mass index (BMI) within the range of 18–30 kg/m². |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to Ropivacaine, Magnesium Sulphate, or local anesthetics. History of coagulopathy or bleeding disorders. Presence of infection at the injection site. Patients with severe systemic diseases (e.g., ASA Physical Status III and above).
Neurological or psychiatric disorders affecting pain perception. Pregnant or lactating women.
Patients on chronic opioid therapy or magnesium supplements. Refusal to consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia, measured as the time from administration of the supraclavicular plexus block to the first request for rescue analgesia. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain intensity, assessed using the Visual Analog Scale (VAS) at 2, 4, 6, 12, and 24 hours postoperatively. |
Evaluated at 2, 4, 6, 12, and 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/05/2025 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
This study aims to compare the efficacy of Ropivacaine alone versus Ropivacaine combined with Magnesium Sulphate for postoperative analgesia in patients undergoing upper limb surgeries under a peripheral nerve stimulator-guided supraclavicular plexus block. The primary outcome is the duration of postoperative analgesia, while secondary outcomes include pain intensity, total rescue analgesic consumption, and the incidence of adverse effects. The study will recruit adult patients aged 18–65 years of both sexes, adhering to strict inclusion and exclusion criteria to ensure safety and reliability of results. |