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

Study Overview
=================
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.

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

Conditions
-----------------
Nausea

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Hydromorphone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone<br>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. | Drug: Oxycodone<br>* 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.<br>* Other names: Supeudol;|
| Active Comparator: Hydromorphone<br>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. | Drug: Hydromorphone<br>* 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.<br>* Other names: Palladone, Dilaudid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily pain scores | Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively | 72 hours after surgery | 
| 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 | 
| Incidence of delirium | The presence of delirium will be recorded until 72 hours post-operatively | 72 hours after surgery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea