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OpenTrials
Completed

NCT Number: NCT05375916

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

Sustained-release hydromorphone is a long-acting preparation opioid

Primary outcomes

  1. Time to Mobilization

    Time frame: Time to mobilize postoperatively up to 5 days

    Ability to walk from bed to chair

Secondary outcomes

  1. Opioid consumption of hydromorphone

    Time frame: Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively

    Consumption of hydromorphone

  2. Pain score

    Time frame: postoperatively day 1, 2, 3

    Pain score using visual analogue scale 0-100

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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