Pain, PostoperativeNCT02880800
Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
A study testing Morphine as IVPCA, Hydromorphone as IVPCA and Morphine in people with Pain, Postoperative, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine as IVPCA, Hydromorphone as IVPCA and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Naveed Siddiqui, 416-586-5270, naveed.siddiqui@uhn.ca
About this study
Official title: Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
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.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine as IVPCA, Hydromorphone as IVPCA, Morphine, Hydromorphone
- Keywords
- Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Pain, Postoperative, Agnosia, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine as IVPCADrug
Also called Morphine
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 IVPCADrug
Also called Dilaudid
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.
MorphineDrug
IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
HydromorphoneDrug
Also called Dilaudid
Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
| Study group | Role | What they receive |
|---|---|---|
| Analgesia, patient controlled | Experimental | Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone. Receives: Drug: Morphine as IVPCA; Drug: Hydromorphone as IVPCA |
| Analgesia, as per needed | Active comparator | Patients will receive intravenous (IV) opioids as per needed. Receives: Drug: Morphine; Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of opioid consumption postoperatively
Measured: Every 24 hours for up to 48 hours after randomization
Secondary outcomes (4)
Opioid related side effects.
Opioid-related Symptom Distress Scale Questionnaire
Measured: Every 24 hours for up to 48 hours after randomization
Patient satisfaction
Patient satisfaction scale as below:
- Very dissatisfied
- Dissatisfied
- Slightly dissatisfied
- Slightly satisfied
- Satisfied
- Very satisfied
Measured: 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
Measured: 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
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveed Siddiqui, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880800
- Sponsor's protocol ID
- 16-0098-A
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
- ClinicalTrials.gov ID
- NCT02880800
- Acronym / sponsor ID
- 16-0098-A
- Conditions
- Pain, Postoperative
- Keywords
- Analgesia, Patient-Controlled, Analgesics, Opioid, Drug-Related Side Effects and Adverse Reactions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgesia, patient controlled | Experimental | Drug: Morphine as IVPCA, Drug: Hydromorphone as IVPCAPatients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone. |
| Analgesia, as per needed | Active comparator | Drug: Morphine, Drug: HydromorphonePatients will receive intravenous (IV) opioids as per needed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine as IVPCAAlso: MorphineMorphine 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 | Drug | Analgesia, patient controlled |
| Hydromorphone as IVPCAAlso: DilaudidHydromorphone 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. | Drug | Analgesia, patient controlled |
| MorphineIV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h) | Drug | Analgesia, as per needed |
| HydromorphoneAlso: DilaudidHydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h) | Drug | Analgesia, as per needed |
Primary outcome
Total amount of opioid consumption postoperatively
Time frame: Every 24 hours for up to 48 hours after randomization
4 secondary outcomes
Opioid related side effects.
Time frame: Every 24 hours for up to 48 hours after randomization
Patient satisfaction
Time frame: Once at 48 hours after randomization
Pain scores measured at rest and movement
Time frame: Every 12 hours for up to 48 hours after randomization
Length of stay in hospital
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine as IVPCA, Hydromorphone as IVPCA and Morphine in people with Pain, Postoperative, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of opioid consumption postoperatively (time frame: Every 24 hours for up to 48 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.