Colorectal CancerPPaMNCT03455751
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
A study testing PGx-guided post-operative pain management in people with Colorectal Cancer and Diverticular Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Diverticular Disease, Crohn Disease
- What is being tested?
- PGx-guided post-operative pain management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 9 Jan 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject capable of giving consent
- Age 18-80
- Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)
Who cannot join
- Patient does not speak English
- Patient with substance-use disorder (including alcohol)
- Patient diagnosed with major depression
- Patient currently taking opioids
- Previous long-term opioid use (> 3 months)
- Previous opioid use with a dose of >100 milligram morphine equivalent (MME)
- Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
- Documented allergy to pain medication
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.
- Being tested
- PGx-guided post-operative pain management
- Keywords
- Pain Management, Pharmacogenomics
- Medical subject headings
- Colorectal Neoplasms, Diverticular Diseases, Crohn Disease, Colitis, Ulcerative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGx-guided post-operative pain managementGenetic
Post-operative pain management as indicated by pharmacogenomic testing results.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control arm will receive no intervention and will follow standard of care for post-operative pain management. |
| PGx-guided | Experimental | The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing. Receives: Genetic: PGx-guided post-operative pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid use
Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Measured: Post-op day 1
Overall Benefit of Analgesia Score (OBAS)
Measured: Post-op day 1
Secondary outcomes (3)
Length of stay
Measured: 30 days
Readmission rate
Measured: 30 days
Functional status
Assessed through Duke Activity Status Index (DASI)
Measured: 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start17 Apr 2018
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Why it stopped: Failed to meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Liska, The Cleveland Clinic
- Investigators
- David Liska, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455751
- Sponsor's protocol ID
- 17-1540
- Acronym
- PPaM
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2018
- Last updated
- 18 Mar 2019
- 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 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03455751
- Acronym / sponsor ID
- PPaM / 17-1540
- Keywords
- Pain Management, Pharmacogenomics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to meet enrollment goals
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 7 Mar 2018 (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 primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control arm will receive no intervention and will follow standard of care for post-operative pain management. |
| PGx-guided | Experimental | Genetic: PGx-guided post-operative pain managementThe PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject capable of giving consent
- Age 18-80
- Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)
Key exclusion criteria (8 listed)
- Patient does not speak English
- Patient with substance-use disorder (including alcohol)
- Patient diagnosed with major depression
- Patient currently taking opioids
- Previous long-term opioid use (> 3 months)
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 |
|---|---|---|
| PGx-guided post-operative pain managementPost-operative pain management as indicated by pharmacogenomic testing results. | Genetic | PGx-guided |
Primary outcome
Post-operative opioid use
Time frame: Post-op day 1
Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Overall Benefit of Analgesia Score (OBAS)
Time frame: Post-op day 1
3 secondary outcomes
Length of stay
Time frame: 30 days
Readmission rate
Time frame: 30 days
Functional status
Time frame: 4 weeks and 3 months
Results and safety
The study was stopped early (reason given: Failed to meet enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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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.
David Liska, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGx-guided post-operative pain management in people with Colorectal Cancer and Diverticular Disease, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Mar 2019. 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 United States. 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 was stopped early (reason given: Failed to meet enrollment goals). Results are not available in the source record.
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?
Post-operative opioid use (time frame: Post-op day 1). The study lists 2 primary outcomes in all. 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 18 Mar 2019.