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Clinical Trials/NCT02880800
NCT02880800
Unknown
Not Applicable

Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?

Mount Sinai Hospital, Canada1 site in 1 country80 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Morphine as IVPCA
Conditions
Pain, Postoperative
Sponsor
Mount Sinai Hospital, Canada
Enrollment
80
Locations
1
Primary Endpoint
Total amount of opioid consumption postoperatively
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
August 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naveed Siddiqui

Assistant professor

Mount Sinai Hospital, Canada

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Analgesia, patient controlled

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

Intervention: Morphine as IVPCA

Analgesia, patient controlled

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

Intervention: Hydromorphone as IVPCA

Analgesia, as per needed

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

Intervention: Morphine

Analgesia, as per needed

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

Intervention: Hydromorphone

Outcomes

Primary Outcomes

Total amount of opioid consumption postoperatively

Time Frame: Every 24 hours for up to 48 hours after randomization

Secondary Outcomes

  • 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 Sites (1)

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