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Opioid

Sustained-Release Opioid for Post-Surgical Pain

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA 1-3

All adult patients undergoing open abdominal urologic surgeries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

Awards & highlights

Study Summary

This trial will study whether a slow-release opioid is better at controlling pain after surgery than a short-acting opioid.

Who is the study for?

This trial is for adults having open abdominal urologic surgeries with a physical status classification of ASA 1-3, which means they're healthy to moderately sedated. People can't join if they refuse participation, have chronic pain, are allergic to hydromorphone, or can't swallow pills.Check my eligibility

What is being tested?

The study is testing the effectiveness of low dose slow-release Hydromorphone (a type of painkiller) in managing post-operative pain for the first 48 hours after surgery compared to shorter-acting pain relief options.See study design

What are the potential side effects?

Hydromorphone may cause side effects like constipation, nausea, drowsiness, dry mouth and potential risk of dependence or withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is good to moderate, with or without severe systemic disease.

Select...

I am an adult scheduled for open abdominal urologic surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Mobilization

Secondary outcome measures

Opioid consumption of hydromorphone

Pain score

Side effects data

From 2015 Phase 4 trial • 84 Patients • NCT02009722

52%

Moderate to Severe Pruritus

40%

Moderate to Severe Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Intrathecal Morphine

Intrathecal Hydromorphone

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sustained-release opioidExperimental Treatment1 Intervention

3mg of sustained-release hydromorphone three times a day

Group II: Short-acting opioidActive Control1 Intervention

1-4 mg of short-acting hydromorphone 2-4 times a day as needed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydromorphone

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,878 Total Patients Enrolled

3 Trials studying Acute Pain

183 Patients Enrolled for Acute Pain

Media Library

Hydromorphone (Opioid) Clinical Trial Eligibility Overview. Trial Name: NCT05375916 — N/A

Acute Pain Research Study Groups: Sustained-release opioid, Short-acting opioid

Acute Pain Clinical Trial 2023: Hydromorphone Highlights & Side Effects. Trial Name: NCT05375916 — N/A

Hydromorphone (Opioid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in the experiment thus far?

"Indeed, the clinicaltrials.gov website affirms that this medical experiment is currently recruiting subjects. It was launched on May 3rd 2022 and updated recently on May 12th 2022; aiming to enroll 80 patients at a single location."

Answered by AI

Are researchers currently recruiting individuals for this experiment?

"Per the information hosted on clinicaltrials.gov, this specific trial is recruiting patients at present. The study was first published on May 3rd 2022 and underwent its most recent update two weeks later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries

2022. "Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05375916.

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