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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880800
• Other study ID #: 16-0098-A
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 25, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Morphine as IVPCA
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
• Hydromorphone as IVPCA
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.
• Morphine
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
• Hydromorphone
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of opioid consumption postoperatively		Every 24 hours for up to 48 hours after randomization	No
Secondary	Opioid related side effects.	Opioid-related Symptom Distress Scale Questionnaire	Every 24 hours for up to 48 hours after randomization	Yes
Secondary	Patient satisfaction	Patient satisfaction scale as below: Very dissatisfied; Dissatisfied; Slightly dissatisfied; Slightly satisfied; Satisfied; Very satisfied	Once at 48 hours after randomization	No
Secondary	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	Every 12 hours for up to 48 hours after randomization	No
Secondary	Length of stay in hospital	The total number of days the study patient was admitted in the hospital for a medical reason	One week	Yes