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patients undergoing lower limb orthopaedic surgeries will be participants divided into two groups and they will be given spinal anaesthesia with bupivacaine and nalbuphine in one group and bupivacaine and fentanyl in another group

Nalbuphine versus Fentanyl as an Intrathecal Adjuvant to Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085739
Enrollment
60
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: S723- Fracture of shaft of femur

Interventions

Control Intervention1: Spinal Anaesthesia: Nalbuphine versus Fentanyl as an Intrathecal Adjuvant to Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeries

Sponsors

Veer Surendra Sai Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18 60 years Belonging to ASA Physical Status I or II Of either sex Undergoing elective lower limb orthopedic surgery under spinal anesthesia

Exclusion criteria

Exclusion criteria: Patients who did not give informed consent Known hypersensitivity to any of the study drugs Pregnancy Coagulation disorders, spinal deformities, local infection at the puncture site, or contraindications to spinal anesthesia

Design outcomes

Primary

MeasureTime frame
Duration of effective postoperative analgesia provided by intrathecal Nalbuphine and Fentanyl when used as adjuvants to hyperbaric Bupivacaine in patients undergoing lower limb orthopedic surgeries. Timepoint: 24 hours—

Secondary

MeasureTime frame
1. To compare the onset time of sensory & motor blockade between the Nalbuphine & Fentanyl groups. 2. To assess the duration of sensory & motor blockade produced by each adjuvant. 3. To evaluate the hemodynamic stability (heart rate, blood pressure variations) intraoperatively & postoperatively in both groups. 4. To compare the incidence of adverse effects, such as nausea, vomiting, pruritus, respiratory depression, bradycardia, & hypotension.Timepoint: 24 hours—

Countries

India

Contacts

Public ContactSanskruti Purohit

Veer Surendra Sai Institute of Medical Sciences and Research

dulalsoren@gmail.com9437254980

Outcome results

None listed

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