search
Back to results

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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Morphine as IVPCA
Hydromorphone as IVPCA
Morphine
Hydromorphone
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Analgesia, patient controlled

Analgesia, as per needed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total amount of opioid consumption postoperatively

Secondary Outcome Measures

Opioid related side effects.
Opioid-related Symptom Distress Scale Questionnaire
Patient satisfaction
Patient satisfaction scale as below: Very dissatisfied Dissatisfied Slightly dissatisfied Slightly satisfied Satisfied Very satisfied
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
Length of stay in hospital
The total number of days the study patient was admitted in the hospital for a medical reason

Full Information

First Posted
August 17, 2016
Last Updated
August 25, 2016
Sponsor
Mount Sinai Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT02880800
Brief Title
Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
Official Title
Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Analgesia, patient controlled
Arm Type
Experimental
Arm Description
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
Arm Title
Analgesia, as per needed
Arm Type
Active Comparator
Arm Description
Patients will receive intravenous (IV) opioids as per needed.
Intervention Type
Drug
Intervention Name(s)
Morphine as IVPCA
Other Intervention Name(s)
Morphine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hydromorphone as IVPCA
Other Intervention Name(s)
Dilaudid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dilaudid
Intervention Description
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
Primary Outcome Measure Information:
Title
Total amount of opioid consumption postoperatively
Time Frame
Every 24 hours for up to 48 hours after randomization
Secondary Outcome Measure Information:
Title
Opioid related side effects.
Description
Opioid-related Symptom Distress Scale Questionnaire
Time Frame
Every 24 hours for up to 48 hours after randomization
Title
Patient satisfaction
Description
Patient satisfaction scale as below: Very dissatisfied Dissatisfied Slightly dissatisfied Slightly satisfied Satisfied Very satisfied
Time Frame
Once at 48 hours after randomization
Title
Pain scores measured at rest and movement
Description
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
Title
Length of stay in hospital
Description
The total number of days the study patient was admitted in the hospital for a medical reason
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui
Phone
416-586-5270
Email
naveed.siddiqui@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs