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

U

University of Alberta

Status

Completed

Conditions

Pain, Acute
Opioid Use

Treatments

Drug: Hydromorphone

Study type

Interventional

Funder types

Other

Identifiers

NCT05375916
Pro00118895

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Sustained-release opioid
Experimental group
Description:
3mg of sustained-release hydromorphone three times a day
Treatment:
Drug: Hydromorphone
Short-acting opioid
Active Comparator group
Description:
1-4 mg of short-acting hydromorphone 2-4 times a day as needed
Treatment:
Drug: Hydromorphone

Trial contacts and locations

1

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Central trial contact

Vivian Ip, MBChB

Data sourced from clinicaltrials.gov

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