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Completed

NCT Number: NCT06577155

Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asklepieion Hospital of Voula

Athens, Ελλάδα (+30), 16675, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

Regional anesthesia / analgesia

Levobupivacaine plus nalbuphine

Drug

Regional anesthesia / analgesia

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours

  2. NRS scores

    Time frame: 48 hours

Secondary outcomes

  1. sensory block level

    Time frame: 1 hour

  2. motor block level

    Time frame: 1 hour

  3. sensory block onset

    Time frame: 1 hour

  4. motor block onset

    Time frame: 1 hour

  5. sensory block duration

    Time frame: 4 hours

  6. motor block duration

    Time frame: 4 hours

  7. Complications

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Collaborators

  • Anastasios Mpontozis

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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