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

NCT05375916 | Completed

• 1 other identifier: Pro00118895
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Opioid Use

Keywords

Postoperative pain; Opioid; Sustained-release opioid

Outcome Measures

Primary Outcomes (1)

• Time to Mobilization

  Ability to walk from bed to chair

  Time to mobilize postoperatively up to 5 days

Secondary Outcomes (2)

• Opioid consumption of hydromorphone

  Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

• Pain score

  postoperatively day 1, 2, 3

Study Arms (2)

Sustained-release opioid

EXPERIMENTAL

3mg of sustained-release hydromorphone three times a day

Drug: Hydromorphone

Short-acting opioid

ACTIVE COMPARATOR

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

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Sustained-release hydromorphone is a long-acting preparation opioid

Short-acting opioid; Sustained-release opioid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 17, 2022
• Study Start: May 3, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

CA (1)