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comparison of two pain relief medicines given through epidural injection after uterus removal surgery

Comparison of Epidural Magnesium sulfate 100 mg versus Fentanyl 25 mcg as adjuvants to 0.125 percent Bupivacaine for postoperative analgesia in patients undergoing Total Abdominal Hysterectomy- A step towards opioid sparing analgesia. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104385
Enrollment
80
Registered
2026-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: N859- Noninflammatory disorder of uterus, unspecified

Interventions

Intervention1: Epidural magnesium sulfate: Patients will receive epidural topup of 8 ml of 0.125 percent bupivacaine combined with magnesium sulfate 100 mg when VAS pain score is 4 or more in postoper

Sponsors

Shivamogga Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 40 to 70 years belonging to ASA physical status I and II scheduled for elective total abdominal hysterectomy under combined spinal epidural anaesthesia and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patient refusal Coagulopathy or bleeding disorders Infection at injection site Known allergy to bupivacaine, magnesium sulfate, or fentanyl Severe cardiac renal or hepatic disease Patients receiving calcium channel blockers or magnesium therapy

Design outcomes

Primary

MeasureTime frame
Duration of postoperative analgesia following epidural administration of study drugs.Timepoint: From epidural drug administration to first request for rescue analgesia.

Secondary

MeasureTime frame
Time of onset of analgesiaTimepoint: From epidural drug administration to achievement of VAS score less than or equal to 2;Pain intensity using Visual Analogue ScaleTimepoint: At 0, 2, 5, 10, 20, 30, 60 minutes and hourly for 6 hours post epidural topup;Hemodynamic parameters heart rate, blood pressure, oxygen saturationTimepoint: Before epidural topup and at 0, 2, 5, 10, 20, 30, 60 minutes and hourly for 6 hours post epidural topup;Incidence of adverse effects like nausea, vomiting, hypotension, pruritis, respiratory depressionTimepoint: During first 24 hours postoperative period

Countries

India

Contacts

Public ContactDr Ashwini S

Shivamogga Institute of Medical Sciences

ashwini.satrasala@gmail.com9980812398

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026