Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

NCT ID: NCT02295124

Last Updated: 2017-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-01-31

Brief Summary

The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.

Detailed Description

Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists.

Conditions

Nausea

Keywords

Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxycodone

Patients will be prescribed oxycodone 10mg (5mg if \> age 65) every 2 hours as needed for post-operative pain management in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

Patients will receive oxycodone 10mg (5mg if \> 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Hydromorphone

Patients will be prescribed hydromorphone 2mg (1mg if \> age 65) every 2 hours as needed in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

Patients will receive an initial dose of hydromorphone 2mg (1mg if \> 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Interventions

Oxycodone

Patients will receive oxycodone 10mg (5mg if \> 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Intervention Type: DRUG

Hydromorphone

Patients will receive an initial dose of hydromorphone 2mg (1mg if \> 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Intervention Type: DRUG

Other Intervention Names

Supeudol; Palladone, Dilaudid

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists Physical Status Classification System 1-3
• Age 18-85 years
• Patients undergoing hip replacement surgery under spinal anesthesia

Exclusion Criteria

• patient refusal
• contraindication or refusal of spinal anesthesia
• inability to provide informed consent
• history of dementia
• intolerance or allergy to oxycodone or hydromorphone
• chronic opioid use or chronic pain disorder
• pregnancy
• history of drug addiction
• history of major psychiatric illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto. University Health Network. Toronto Western Hospital.

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.

Reference Type: BACKGROUND

PMID: 10475299 (View on PubMed)

Pavlin DJ, Rapp SE, Polissar NL, Malmgren JA, Koerschgen M, Keyes H. Factors affecting discharge time in adult outpatients. Anesth Analg. 1998 Oct;87(4):816-26. doi: 10.1097/00000539-199810000-00014.

Reference Type: BACKGROUND

PMID: 9768776 (View on PubMed)

Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.

Reference Type: BACKGROUND

PMID: 19302899 (View on PubMed)

Other Identifiers

12-0267-AE

Identifier Type: -

Identifier Source: org_study_id