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

NCT ID: NCT05375916

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2023-11-30

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.

Conditions

Pain, Acute; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sustained-release opioid

3mg of sustained-release hydromorphone three times a day

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Sustained-release hydromorphone is a long-acting preparation opioid

Short-acting opioid

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

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

Sustained-release hydromorphone is a long-acting preparation opioid

Interventions

Hydromorphone

Sustained-release hydromorphone is a long-acting preparation opioid

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00118895

Identifier Type: -

Identifier Source: org_study_id