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

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05602519

Collaborator

(none)

100

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

37.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty The Analgesic Efficacy	Drug: propofol, rocuronium and fentanyl	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 10, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group fentanyl Patients will receive 50 mg of fentanyl 20 min before the end of surgery.	Drug: propofol, rocuronium and fentanyl In fentanyl group (50 patients), 50 mg 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.
Active Comparator: Group oxycodone Patients will receive 4 mg of oxycodone 20 min before the end of surgery.	Drug: propofol, rocuronium and fentanyl In fentanyl group (50 patients), 50 mg 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.

Arm

Intervention/Treatment

Active Comparator: Group fentanyl

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

Drug: propofol, rocuronium and fentanyl

In fentanyl group (50 patients), 50 mg 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.

Active Comparator: Group oxycodone

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

Drug: propofol, rocuronium and fentanyl

In fentanyl group (50 patients), 50 mg 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.

Outcome Measures

Primary Outcome Measures

Improving A post-anesthesia care unit (PACU) pain score. [2 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 Outcome Measures

Hemodynamics [2 hours]
Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure.
Intraoperative need for analgesia [2 hours]
The number of patients who will require intraoperative fentanyl will be recorded
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 62 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facualty of Medicine (Damietta), Al Azhar University	Damieta		Egypt	34711

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05602519

Other Study ID Numbers:

IRB 00012367-22-010-005

First Posted:

Nov 2, 2022

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

Oxycodone Hydrochloride

Fentanyl

Additional relevant MeSH terms:

Fentanyl

Propofol

Rocuronium

Study Results

No Results Posted as of Jan 17, 2023