Pain, AcuteNCT05375916
Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries
A study testing Hydromorphone in people with Pain, Acute and Opioid Use, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain, Acute, Opioid Use
- What is being tested?
- Hydromorphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients undergoing open abdominal urologic surgeries
- ASA 1-3
Who cannot join
- Patient refusal
- history of chronic pain
- allergy to hydromorphone
- cannot swallow tablets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following 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.
Read the 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.
- Conditions
- Pain, Acute, Opioid Use
- Being tested
- Hydromorphone
- Keywords
- Postoperative pain, Opioid, Sustained-release opioid
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Sustained-release hydromorphone is a long-acting preparation opioid
| Study group | Role | What they receive |
|---|---|---|
| Sustained-release opioid | Experimental | 3mg of sustained-release hydromorphone three times a day Receives: Drug: Hydromorphone |
| Short-acting opioid | Active comparator | 1-4 mg of short-acting hydromorphone 2-4 times a day as needed Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Mobilization
Ability to walk from bed to chair
Measured: Time to mobilize postoperatively up to 5 days
Secondary outcomes (2)
Opioid consumption of hydromorphone
Consumption of hydromorphone
Measured: Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
Pain score
Pain score using visual analogue scale 0-100
Measured: postoperatively day 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start3 May 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375916
- Sponsor's protocol ID
- Pro00118895
- Status last verified
- May 2024
- First submitted
- 27 Apr 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries
- ClinicalTrials.gov ID
- NCT05375916
- Acronym / sponsor ID
- Pro00118895
- Conditions
- Pain, Acute, Opioid Use
- Keywords
- Postoperative pain, Opioid, Sustained-release opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained-release opioid | Experimental | Drug: Hydromorphone3mg of sustained-release hydromorphone three times a day |
| Short-acting opioid | Active comparator | Drug: Hydromorphone1-4 mg of short-acting hydromorphone 2-4 times a day as needed |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients undergoing open abdominal urologic surgeries
- ASA 1-3
Key exclusion criteria (4 listed)
- Patient refusal
- history of chronic pain
- allergy to hydromorphone
- cannot swallow tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneSustained-release hydromorphone is a long-acting preparation opioid | Drug | Short-acting opioid, Sustained-release opioid |
Primary outcome
Time to Mobilization
Time frame: Time to mobilize postoperatively up to 5 days
Ability to walk from bed to chair
2 secondary outcomes
Opioid consumption of hydromorphone
Time frame: Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively
Pain score
Time frame: postoperatively day 1, 2, 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydromorphone in people with Pain, Acute and Opioid Use, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Mobilization (time frame: Time to mobilize postoperatively up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.