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A Study to Compare Two Pain Medicines given with a Numbing Drug Through a Tube in the Back to Control Pain After Lower Umbilical Surgery

Efficacy of Nalbuphine versus Fentanyl as Epidural Adjuvants to Bupivacaine for Postoperative Analgesia in Infraumbilical Surgeries: A Comparative Study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097177
Enrollment
60
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

None listed

Interventions

Intervention1: Nalbuphine: Single-shot Nalbuphine 10mg will be given along with 0.125% Bupivacaine diluted to 10 mL in normal saline via epidural catheter, postoperatively when sensory level drops to

Sponsors

Vinayaka Missions Kirupananda Variyar Medical College & Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA Physical Status 1 and 2 2. Patients undergoing elective infraumbilical surgeries under combined spinal-epidural anaesthesia 3. Patients willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Patients on opioids, tricyclic antidepressants, or alpha-2 agonists 2. Patients with coagulation defects and patients on anticoagulants 3. Patients with neuromuscular disorders 4. Patients with disease and deformities of spinal cord 5. Patients allergic to local anaesthetic drugs

Design outcomes

Primary

MeasureTime frame
Duration of postoperative analgesia, defined as the time from epidural drug administration to the first request for rescue analgesiaTimepoint: 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug

Secondary

MeasureTime frame
Pain scores at rest & movement using the Visual Analog Scale (VAS) at predefined time intervalsTimepoint: From 0 min of administering drug & 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug;Incidence of side effects & derangement in haemodynamic parametersTimepoint: From 0 min of administering drug & 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug

Countries

India

Contacts

Public ContactDr Aupama M

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

mskbrins63@gmail.com9443247021

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026