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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Opioid Use

Intervention / Treatment
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* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained-release opioid<br>3mg of sustained-release hydromorphone three times a day | Drug: Hydromorphone<br>* Sustained-release hydromorphone is a long-acting preparation opioid<br>|
| Active Comparator: Short-acting opioid<br>1-4 mg of short-acting hydromorphone 2-4 times a day as needed | Drug: Hydromorphone<br>* Sustained-release hydromorphone is a long-acting preparation opioid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Mobilization | Ability to walk from bed to chair | Time to mobilize postoperatively up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption of hydromorphone | Consumption of hydromorphone | Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively | 
| Pain score | Pain score using visual analogue scale 0-100 | postoperatively day 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Postoperative pain, Sustained-release opioid