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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375916
• Other study ID #: Pro00118895
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use
• Pain, Acute

Intervention

Drug:
• Hydromorphone
Sustained-release hydromorphone is a long-acting preparation opioid

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Mobilization	Ability to walk from bed to chair	Time to mobilize postoperatively up to 5 days
Secondary	Opioid consumption of hydromorphone	Consumption of hydromorphone	Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
Secondary	Pain score	Pain score using visual analogue scale 0-100	postoperatively day 1, 2, 3