| CTRI Number |
CTRI/2025/08/092789 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Fentanyl and Magnesium sulphate with Bupivacaine to Improve Pain Relief for Arm Surgery Using Ultrasound guided Nerve Block at SMS Medical College, Jaipur. |
|
Scientific Title of Study
|
A Randomized comparative Study to Evaluate the Efficacy of Fentanyl and Magnesium Sulphate as an Adjuvant to 0.375% bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block in S.M.S Medical College Jaipur. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shriphal Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, S.M.S Medical College, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriphal Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, S.M.S Medical College, JLN Marg, Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth Eshwar |
| Designation |
PG Resident |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, S.M.S Medical College, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9840592293 |
| Fax |
|
| Email |
siddharth.dashiell@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 2nd Floor, Dhanvantri Complex, S.M.S Medical College and hospital, Jaipur 302004, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
S.M.S Medical College and Hospital |
| Address |
Department of Anaesthesiology, 2nd Floor, Dhanvantri Complex, S.M.S Medical College and hospital, Jaipur 302004, Rajasthan, India |
| 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 |
| Dr Shriphal Meena |
Orthopedic Surgery Operation Theatre, S.M.S Medical College, Jaipur |
Department of Anaesthesiology, 2nd Floor, Dhanvantri Complex, S.M.S Medical College, Jaipur
Jaipur
RAJASTHAN |
9928350391
dr.shriphal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, S.M.S Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T230||Burn of unspecified degree of wrist and hand, (2) ICD-10 Condition: M200||Deformity of finger(s), (3) ICD-10 Condition: S424||Fracture of lower end of humerus, (4) ICD-10 Condition: S525||Fracture of lower end of radius, (5) ICD-10 Condition: S621||Fracture of other and unspecifiedcarpal bone(s), (6) ICD-10 Condition: S520||Fracture of upper end of ulna, (7) ICD-10 Condition: M674||Ganglion, (8) ICD-10 Condition: S561||Injury of flexor muscle, fascia and tendon of other and unspecified finger at forearm level, (9) ICD-10 Condition: S669||Injury of unspecified muscle, fascia and tendon at wrist and hand level, (10) ICD-10 Condition: S518||Open wound of forearm, (11) ICD-10 Condition: M651||Other infective (teno)synovitis, (12) ICD-10 Condition: S680||Traumatic metacarpophalangeal amputation of thumb, (13) ICD-10 Condition: M653||Trigger finger, (14) ICD-10 Condition: S529||Unspecified fracture of forearm, (15) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl Group |
Received 20 ml of 0.375% Bupivacaine with Fentanyl 50 micrograms, administered as a single-shot ultrasound-guided supraclavicular brachial plexus block prior to upper limb surgery. |
| Comparator Agent |
Magnesium Sulfate Group |
Received 20 ml of 0.375% Bupivacaine with Magnesium Sulphate 150 mg, administered as a single-shot ultrasound-guided supraclavicular brachial plexus block prior to upper limb surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who provide informed written consent.
2.Patients scheduled for elective upper limb surgeries distal to the mid-humerus, planned under ultrasound-guided supraclavicular brachial plexus block.
3.Adult patients of either sex aged more than 18 years.
4.Patients with American Society of Anaesthesiologists (ASA) physical status I or II. |
|
| ExclusionCriteria |
| Details |
1.Patients with a known allergy to any of the study drugs (bupivacaine, fentanyl, or magnesium sulphate).
2.Pregnant or breastfeeding women.
3.Patients with liver, kidney, or heart problems.
4.Patients with other medical conditions such as high blood pressure, diabetes, bleeding disorders, or skin infection at the injection site.
5.Patients who are currently participating in another clinical study. |
|
|
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 |
1. To determine and compare the difference in onset and duration of motor blockade in
both the groups.
2. To determine and compare the difference in onset and duration of sensory blockade in both the groups. |
Onset time of motor block (minutes) measured from completion of local anesthetic injection to attainment of Modified Bromage score 3.
Duration of motor block (minutes) measured from completion of local anesthetic injection to return to Modified Bromage score 0 checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr.
Onset time of sensory block (minutes) measured from completion of local anesthetic injection to loss of pin-prick sensation at target dermatome.
Duration of sensory block (minutes) measured from completion of local anesthetic injection to return of pin-prick sensation at target dermatome checked postoperatively at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine and compare total duration of analgesia between both the groups. |
Duration of analgesia (minutes) will be defined as the time between the end of local anesthetic administration and the first analgesic request. |
To determine and compare postoperative analgesia using VAS score between both the
groups. |
Post operatively VAS Score will be checked at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. |
| To determine hemodynamic parameters between both the groups. |
Intra operatively heart rate, non-invasive blood pressure and SpO2 will be checked
every 5 minutes for the first half hour and every 15 minutes thereafter. Post operatively, heart rate, non-invasive blood pressure will be checked at 0 min, 30 min, 1hr, 2hr, 3hr, 6hr, 12hr, 24hr. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| 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="5"
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
|
This prospective, randomized comparative study is being conducted at S.M.S Medical College and Hospital, Jaipur to compare the effectiveness of adding magnesium sulfate to 0.375% bupivacaine and fentanyl to 0.375% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients undergoing elective upper limb surgeries distal to mid-humerus. A total of 66 patients will be enrolled and randomized into two equal groups (Fentanyl group and Magnesium sulfate group). Parameters such as onset of motor block, duration of motor block, onset of sensory block, duration of sensory block, total duration of analgesia, VAS score, intraoperative and postoperative hemodynamic changes will be recorded at predefined time intervals. The aim is to identify the more effective adjuvant fentanyl or magnesium sulfate, when combined with 0.375% bupivacaine, thereby improving patient comfort, reducing analgesic requirements, and ensuring hemodynamic stability with minimal adverse effects. |