Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?

NCT02880800 | Unknown

• 1 other identifier: 16-0098-A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. The investigators assumed that with the multimodal analgesia regimen without the use of IVPCA will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.

Conditions

Pain, Postoperative

Keywords

Analgesia, Patient-Controlled; Analgesics, Opioid; Drug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (1)

• Total amount of opioid consumption postoperatively

  Every 24 hours for up to 48 hours after randomization

Secondary Outcomes (4)

• Opioid related side effects.

  Every 24 hours for up to 48 hours after randomization

• Patient satisfaction

  Once at 48 hours after randomization

• Pain scores measured at rest and movement

  Every 12 hours for up to 48 hours after randomization

• Length of stay in hospital

  One week

Study Arms (2)

Analgesia, patient controlled

EXPERIMENTAL

Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.

Drug: Morphine as IVPCA; Drug: Hydromorphone as IVPCA

Analgesia, as per needed

ACTIVE COMPARATOR

Patients will receive intravenous (IV) opioids as per needed.

Drug: Morphine; Drug: Hydromorphone

Interventions

Morphine as IVPCA DRUG

Morphine as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of morphine as below: Morphine bolus 1mg with a lockout interval of 5 minutes, no background infusion and maximum 30 mg in 4 hours

Also known as: Morphine

Analgesia, patient controlled

Hydromorphone as IVPCA DRUG

Hydromorphone as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of Hydromorphone as below: Hydromorphone bolus 0.2 mg with a lockout interval of 5 minutes and a maximum dose of 6 mg in 4 hours.

Also known as: Dilaudid

Analgesia, patient controlled

Morphine DRUG

IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)

Analgesia, as per needed

Hydromorphone DRUG

Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)

Also known as: Dilaudid

Analgesia, as per needed

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 to 80 years old
• Provision of written informed consent
• Patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only
• Patients with Body Mass Index (BMI) between 18 to 34.9
• Patients with American Society of Anesthesiologists (ASA) physical status classification of 1 to 3

You may not qualify if:

• Patients on chronic (more than twice a week) opioid treatment including Tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids
• Patients with language barrier or difficulty in communication in English
• Patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen
• Patients with increased risk for respiratory depression with intrathecal morphine (OSA, central apnea)
• Patients with documented Renal or hepatic impairment

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Drug-Related Side Effects and Adverse Reactions

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)