Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

Phase 2

Not yet recruiting

• Conditions: Total Hip Arthroplasty; Analgesia
• Interventions: Drug: Levobupivacaine plus nalbuphine; Drug: Levobupivacaine

• Registration Number: NCT06577155
• Lead Sponsor: Asklepieion Voulas General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-30
• Study Start: 2024-09
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Physical status according to American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for total hip arthroplasty

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Exclusion Criteria

• BMI above 40
• Serious psychiatric, mental and cognitive disorders
• Contraindication for central and/or peripheral nervous blockade
• History of allergic or other adverse reactions on the agents used in the study
• Chronic opioid

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N	Levobupivacaine plus nalbuphine	Spinal levobupivacaine plus nalbuphine
E	Levobupivacaine	Spinal levobupivacaine

Primary Outcome Measures

Name	Time	Method
Morphine consumption	24 hours
NRS scores	48 hours

Secondary Outcome Measures

Name	Time	Method
sensory block onset	1 hour
motor block onset	1 hour
sensory block level	1 hour
motor block level	1 hour
sensory block duration	4 hours
motor block duration	4 hours
Complications	24 hours

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Ελλάδα (+30), Greece