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

NCT ID: NCT05602519

Last Updated: 2023-08-07

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-05-30

Brief Summary

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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).

Detailed Description

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Conditions

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Total Hip Arthroplasty The Analgesic Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group fentanyl

Patients will receive 50 ug of fentanyl 20 min before the end of surgery.

Group Type ACTIVE_COMPARATOR

propofol, rocuronium and fentanyl

Intervention Type 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.

Group oxycodone

Patients will receive 4 mg of oxycodone 20 min before the end of surgery.

Group Type ACTIVE_COMPARATOR

propofol, rocuronium and fentanyl

Intervention Type 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.

Interventions

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propofol, 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facualty of Medicine (Damietta), Al Azhar University

Damietta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB 00012367-22-010-005

Identifier Type: -

Identifier Source: org_study_id

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