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

University Health Network, Toronto

Status and phase: Completed; Phase 4

Conditions: Nausea

Treatments: Drug: Hydromorphone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02295124

12-0267-AE

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Oxycodone

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone

Hydromorphone

Active Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone