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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295124
• Other study ID #: 12-0267-AE
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2013
• Last updated: November 22, 2017
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of postoperative nausea	The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively	Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary	Daily pain scores	Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively	72 hours after surgery
Secondary	Incidence of opioid related itching	The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively	72 hours after surgery
Secondary	Incidence of delirium	The presence of delirium will be recorded until 72 hours post-operatively	72 hours after surgery
Secondary	Cumulative in-hospital opioid consumption	Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively	72 hours after surgery
Secondary	Use of anti-nausea medications	The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively	72 hours after surgery
Secondary	Cumulative drug costs per patient	The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively	72 hours after surgery
Secondary	Post-operative admission duration	The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours	Total admission duration, an expected average of 72 hours