MedPath

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

Not Applicable
Completed
Conditions
Pain, Acute
Opioid Use
Interventions
Registration Number
NCT05375916
Lead Sponsor
University of Alberta
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sustained-release opioidHydromorphone3mg of sustained-release hydromorphone three times a day
Short-acting opioidHydromorphone1-4 mg of short-acting hydromorphone 2-4 times a day as needed
Primary Outcome Measures
NameTimeMethod
Time to MobilizationTime to mobilize postoperatively up to 5 days

Ability to walk from bed to chair

Secondary Outcome Measures
NameTimeMethod
Pain scorepostoperatively day 1, 2, 3

Pain score using visual analogue scale 0-100

Opioid consumption of hydromorphonePostoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

Consumption of hydromorphone

Trial Locations

Locations (1)

University of Alberta Hospital

🇨🇦

Edmonton, Alberta, Canada

© Copyright 2025. All Rights Reserved by MedPath