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

Primary Purpose

Pain, Acute, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hydromorphone
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Postoperative pain, Opioid, Sustained-release opioid

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sustained-release opioid

Short-acting opioid

Arm Description

3mg of sustained-release hydromorphone three times a day

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

Outcomes

Primary Outcome Measures

Time to Mobilization
Ability to walk from bed to chair

Secondary Outcome Measures

Opioid consumption of hydromorphone
Consumption of hydromorphone
Pain score
Pain score using visual analogue scale 0-100

Full Information

First Posted
April 27, 2022
Last Updated
May 15, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05375916
Brief Title
Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries
Official Title
Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Opioid Use
Keywords
Postoperative pain, Opioid, Sustained-release opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sustained-release opioid
Arm Type
Experimental
Arm Description
3mg of sustained-release hydromorphone three times a day
Arm Title
Short-acting opioid
Arm Type
Active Comparator
Arm Description
1-4 mg of short-acting hydromorphone 2-4 times a day as needed
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Sustained-release hydromorphone is a long-acting preparation opioid
Primary Outcome Measure Information:
Title
Time to Mobilization
Description
Ability to walk from bed to chair
Time Frame
Time to mobilize postoperatively up to 5 days
Secondary Outcome Measure Information:
Title
Opioid consumption of hydromorphone
Description
Consumption of hydromorphone
Time Frame
Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
Title
Pain score
Description
Pain score using visual analogue scale 0-100
Time Frame
postoperatively day 1, 2, 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Ip, MBChB
Phone
780407 7361
Email
hip@ualberta.ca
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Ip, MBChB

12. IPD Sharing Statement

Learn more about this trial

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

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