Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Total Hip Arthroplasty Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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E

Spinal levobupivacaine

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Regional anesthesia / analgesia

N

Spinal levobupivacaine plus nalbuphine

Group Type ACTIVE_COMPARATOR

Levobupivacaine plus nalbuphine

Intervention Type DRUG

Regional anesthesia / analgesia

Interventions

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Levobupivacaine

Regional anesthesia / analgesia

Intervention Type DRUG

Levobupivacaine plus nalbuphine

Regional anesthesia / analgesia

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No