NCT06577155

Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

The Effect of Nalbuphine as an Adjuvant to Levobupivacaine in Subarachnoid Anesthesia in Total Hip Arthroplasty. A Double-blind, Randomized, Controlled Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Asklepieion Voulas General Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.

Conditions

• Total Hip Arthroplasty
• Analgesia

Interventions

Type	Name	Description
DRUG	Levobupivacaine	Regional anesthesia / analgesia
DRUG	Levobupivacaine plus nalbuphine	Regional anesthesia / analgesia

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-08-29
• Last updated: 2024-09-19

Locations

1 site across 1 country: Greece