RecruitingPhase 2NCT06577155

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.


Sponsor

Asklepieion Voulas General Hospital

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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

Exclusion Criteria5

  • 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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Interventions

DRUGLevobupivacaine

Regional anesthesia / analgesia

DRUGLevobupivacaine plus nalbuphine

Regional anesthesia / analgesia


Locations(1)

Asklepieion Hospital of Voula

Athens, Ελλάδα (+30), Greece

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NCT06577155


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