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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
8 months
August 27, 2024
September 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Morphine consumption
24 hours
NRS scores
48 hours
Secondary Outcomes (7)
sensory block level
1 hour
motor block level
1 hour
sensory block onset
1 hour
motor block onset
1 hour
sensory block duration
4 hours
- +2 more secondary outcomes
Study Arms (2)
E
ACTIVE COMPARATORSpinal levobupivacaine
N
ACTIVE COMPARATORSpinal levobupivacaine plus nalbuphine
Interventions
Eligibility Criteria
You may qualify if:
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total hip arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asklepieion Voulas General Hospitallead
- Anastasios Mpontoziscollaborator
Study Sites (1)
Asklepieion Hospital of Voula
Athens, Ελλάδα (+30), 16675, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anaesthesiologist
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
September 1, 2024
Primary Completion
May 1, 2025
Study Completion
June 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share