Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

May 11, 2026 updated by: Alexandros Makris, Asklepieion Voulas General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Ελλάδα (+30)
      • Athens, Ελλάδα (+30), Greece, 16675
        • Asklepieion Hospital of Voula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: E
Spinal levobupivacaine
Drug: Levobupivacaine
Regional anesthesia / analgesia
Active Comparator: N
Spinal levobupivacaine plus nalbuphine
Drug: Levobupivacaine plus nalbuphine
Regional anesthesia / analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphine consumption
Time Frame: 24 hours
24 hours
NRS scores
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 24 hours
24 hours
sensory block level
Time Frame: 1 hour
1 hour
motor block level
Time Frame: 1 hour
1 hour
sensory block onset
Time Frame: 1 hour
1 hour
motor block onset
Time Frame: 1 hour
1 hour
sensory block duration
Time Frame: 4 hours
4 hours
motor block duration
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepieion Voulas General Hospital

Collaborators

Anastasios Mpontozis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Actual)

January 21, 2025

Study Completion (Actual)

January 21, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10542/22-05-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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