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

Mount Sinai Hospital, Canada80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Hydromorphone as IVPCADRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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.

Opioid-related Symptom Distress Scale Questionnaire

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

Patient satisfaction

Patient satisfaction scale as below: 1. Very dissatisfied 2. Dissatisfied 3. Slightly dissatisfied 4. Slightly satisfied 5. Satisfied 6. Very satisfied

Time frame: Once at 48 hours after randomization

Pain scores measured at rest and movement

Based on verbal analogue scale (VAS) scoring system (0-10), where score of 0 refers to no pain and a score of 10 refers to the worst pain imaginable

Time frame: Every 12 hours for up to 48 hours after randomization

Length of stay in hospital

The total number of days the study patient was admitted in the hospital for a medical reason

Time frame: One week