The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:

The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05602519

Enrollment

Registered

2022-11-02

Start date

2022-11-10

Completion date

2023-05-30

Last updated

2023-08-07

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

Conditions

The Analgesic Efficacy, Total Hip Arthroplasty

Keywords

Oxycodone Hydrochloride, Fentanyl

Brief summary

Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).

Interventions

DRUGpropofol, rocuronium and fentanyl

In fentanyl group (36 patients), 50 ug of fentanyl, and in oxycodone group, 4 mg of oxycodone will be administered 20 minutes before the end of the surgery, in triple blind manner.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Years to 62 Years

Healthy volunteers

Inclusion criteria

* Patients aged 28-62 years old, * Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.

Exclusion criteria

* Patients with history of any kind of drug allergy. * drug abuse. * psychological or other emotional problems, * renal and hepatic chronic disease.

Design outcomes

Primary

Measure	Time frame	Description
Improving A post-anesthesia care unit (PACU) pain score.	48 hours	The visual analogue scale (VAS) will be used for assessment of postoperative pain severity (0 for no pain and 10 for the most severe pain).

Secondary

Measure	Time frame	Description
Hemodynamics	48 hours	Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure.
Postoperative side effects	48 hours	Any side effects will be documented. Postoperative nausea and vomiting (if occurred) will be treated by intravenous administration of metoclopramide (10mg).
Postoperative consumption of opioid	48 hours postoperatively	The overall dose of fentanyl administrated in the first 48 postoperative hours will be documented at 6, 12, 24 and 48 hours.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026