Sustained-release opioid for Pain, Acute

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta Hospital, Edmonton, Canada
Pain, Acute+2 More
Hydromorphone - Drug
Eligibility
18+
All Sexes
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Study Summary

The advantage of slow-release opioid allows for less fluctuation in drug (pain killer) levels in the blood and an extended period within the effective range for pain relief. The slow-release opioids have been preferred over the short-acting opioids because of the longer duration of action, which lessens the frequency and severity of end-of-dose pain. Herein, the investigators propose the use of low dose slow-release opioid formulation offers better pain control in the first 48 hours post-operatively in open abdominal urologic surgeries.

Eligible Conditions

  • Pain, Acute
  • Opioids Use

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pain, Acute

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

Hour 72
Opioid consumption of hydromorphone
Day 5
Time to Mobilization
Day 1
Pain score

Trial Safety

Safety Progress

1 of 3

Other trials for Pain, Acute

Side Effects for

Intrathecal Hydromorphone
66%Moderate to Severe Pruritus
32%Moderate to Severe Nausea
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02009722) in the Intrathecal Hydromorphone ARM group. Side effects include: Moderate to Severe Pruritus with 66%, Moderate to Severe Nausea with 32%.

Trial Design

2 Treatment Groups

Short-acting opioid
1 of 2
Sustained-release opioid
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Sustained-release opioid · No Placebo Group · N/A

Sustained-release opioid
Drug
Experimental Group · 1 Intervention: Hydromorphone · Intervention Types: Drug
Short-acting opioid
Drug
ActiveComparator Group · 1 Intervention: Hydromorphone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydromorphone
2005
Completed Phase 4
~4290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
Closest Location: University of Alberta Hospital · Edmonton, Canada
Photo of university of alberta hospital  1Photo of university of alberta hospital  2Photo of university of alberta hospital  3
2009First Recorded Clinical Trial
2 TrialsResearching Pain, Acute
275 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.