Skip to main content
OpenTrials
Completed

NCT Number: NCT02295124

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Oxycodone

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.

Other names: Supeudol

Hydromorphone

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.

Other names: Palladone, Dilaudid

Primary outcomes

  1. The occurrence of postoperative nausea

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours

    The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively

Secondary outcomes

  1. Daily pain scores

    Time frame: 72 hours after surgery

    Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively

  2. Incidence of opioid related itching

    Time frame: 72 hours after surgery

    The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively

  3. Incidence of delirium

    Time frame: 72 hours after surgery

    The presence of delirium will be recorded until 72 hours post-operatively

  4. Cumulative in-hospital opioid consumption

    Time frame: 72 hours after surgery

    Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively

  5. Use of anti-nausea medications

    Time frame: 72 hours after surgery

    The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively

  6. Cumulative drug costs per patient

    Time frame: 72 hours after surgery

    The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively

  7. Post-operative admission duration

    Time frame: Total admission duration, an expected average of 72 hours

    The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Nov 27, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.