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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06577155

Enrollment

Registered

2024-08-29

Start date

2024-08-29

Completion date

2025-01-21

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Total Hip Arthroplasty

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.

Interventions

DRUGLevobupivacaine

Regional anesthesia / analgesia

DRUGLevobupivacaine plus nalbuphine

Regional anesthesia / analgesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Morphine consumption	24 hours
NRS scores	48 hours

Secondary

Measure	Time frame
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
motor block duration	4 hours
Complications	24 hours

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026