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

Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375916
Enrollment
80
Registered
2022-05-17
Start date
2022-05-03
Completion date
2023-11-30
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Pain, Acute

Keywords

Postoperative pain, Opioid, Sustained-release opioid

Brief 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.

Detailed description

This will be a randomized, double-blind, controlled trial looking at all adult patients undergoing open abdominal urologic surgeries. After assessing the inclusion/exclusion criteria, the patients will be randomized into one of two groups: Group 1: Sustained-release (long-acting) opioid on a regular basis for 2 days with immediate-release (short-acting) opioid available on an 'as required' basis Group 2: Immediate-release (short-acting) opioid on an 'as required' basis only. All patients will have a general anesthetic at the discretion of the anesthesiologist in the operating room and intravenous opioid will be administered in accordance with the anesthesiologists' discretion. Pain score and analgesic consumption are the outcome measures.

Interventions

DRUGHydromorphone

Sustained-release hydromorphone is a long-acting preparation opioid

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients undergoing open abdominal urologic surgeries * ASA 1-3

Exclusion criteria

* Patient refusal * history of chronic pain * allergy to hydromorphone * cannot swallow tablets

Design outcomes

Primary

MeasureTime frameDescription
Time to MobilizationTime to mobilize postoperatively up to 5 daysAbility to walk from bed to chair

Secondary

MeasureTime frameDescription
Opioid consumption of hydromorphonePostoperatively in recovery, 24 hours, 48 hours and 72 hours postoperativelyConsumption of hydromorphone
Pain scorepostoperatively day 1, 2, 3Pain score using visual analogue scale 0-100

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026