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OpenTrials
Completed

NCT Number: NCT05602519

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

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).

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Key information

Conditions

Total Hip Arthroplasty The Analgesic Efficacy

Age range

28 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facualty of Medicine (Damietta), Al Azhar University

Damietta, 34711, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

propofol, rocuronium and fentanyl

Drug

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.

Primary outcomes

  1. Improving A post-anesthesia care unit (PACU) pain score.

    Time frame: 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 outcomes

  1. Hemodynamics

    Time frame: 48 hours

    Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure.

  2. Postoperative side effects

    Time frame: 48 hours

    Any side effects will be documented. Postoperative nausea and vomiting (if occurred) will be treated by intravenous administration of metoclopramide (10mg).

  3. Postoperative consumption of opioid

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Aug 7, 2023

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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