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.

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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092789

Enrollment

Registered

2025-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T230- Burn of unspecified degree of wrist and hand Health Condition 2: M200- Deformity of finger(s) Health Condition 3: S424- Fracture of lower end of humerus Health Condition 4: S525- Fracture of lower end of radius Health Condition 5: S621- Fracture of other and unspecifiedcarpal bone(s) Health Condition 6: S520- Fracture of upper end of ulna Health Condition 7: M674- Ganglion Health Condition 8: S561- Injury of flexor muscle, fascia and tendon of other and unspecified fing

Interventions

Intervention1: 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 li

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Secondary

Measure	Time frame
To determine and compare total duration of analgesia between both the groups.Timepoint: 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.Timepoint: 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.Timepoint: 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.	—

Measure

Time frame

To determine and compare total duration of analgesia between both the groups.Timepoint: 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.Timepoint: 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.Timepoint: 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.

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Countries

India

Contacts

Public ContactDr Siddharth Eshwar

Sawai Man Singh Medical College and Hospital

dr.shriphal@gmail.com9928350391

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026