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To compare Nalbuphine over Fentanyl as adjuvant to Bupivacaine during spinal anaesthesia in Cesarean cases

Nalbuphine over Fentanyl as adjuvant to intrathecal Bupivacaine in Cesarean cases-Randomised Double Blind Control - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095291
Enrollment
48
Registered
2025-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O997- Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium Health Condition 2: O997- Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: NALBUPHINE 0.8mg : Nalbuphine (0.8mg)single dose is used as an adjuvant to Bupivacaine(0.5%) in spinal anaesthesia intrathecal route of administration during the intervention performed

Sponsors

DR SANCHITA ROY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing elective cesarean section under spinal anaesthesia. 2)Patients belonging to ASA physical status Grade I, Grade II. 3)Patients who have given informed and written consent.

Exclusion criteria

Exclusion criteria: 1)Patients allergic to study drug 2)Patients with any contraindication to spinal procedure 3)Failed spinal anaesthesia in patients

Design outcomes

Primary

MeasureTime frame
To assess whether Nalbuphine(0.8mg) causes pruritus as an intrathecal adjuvant to 0.5% hyperbaric Bupivacaine similar to FentanylTimepoint: Immediately after intrathecal administration during spinal anaesthesia and then every 1 hour till 24hours from the time of administration.—

Secondary

MeasureTime frame
To compare the sensory & motor block characteristics & duration of post operative analgesia of Nalbuphine & Fentanyl as intrathecal adjuvants to 0.5% hyperbaric Bupivacaine.Timepoint: Immediately after intrathecal administration of spinal anaesthesia, 5, 10 minutes to look for onset of sensory & motor block. 1 hour, 2 hours, 3 hours, 6hours, 12hours to look for duration of sensory & motor block & for duration of post operative analgesia.—

Countries

India

Contacts

Public ContactSANCHITA ROY

Senior Consutant Anaesthesiology ,Central Hospital Maligaon ,N F Railway

dranirudha85@gmail.com9957550517

Outcome results

None listed

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