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

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Drug: Hydromorphone as IVPCA; Drug: Morphine as IVPCA; Drug: Morphine; Drug: Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT02880800

16-0098-A

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Analgesia, patient controlled

Experimental group

Description:

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

Treatment:

Drug: Morphine as IVPCA

Drug: Hydromorphone as IVPCA

Analgesia, as per needed

Active Comparator group

Description:

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

Treatment:

Drug: Hydromorphone

Drug: Morphine