Perioperative/Postoperative ComplicationsNCT03579121
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
A study testing Pharmacogenomic (PGx) and Review results in people with Perioperative/Postoperative Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Pharmacogenomic (PGx) and Review results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 1 Apr 2022
- 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
- Patients undergoing primary total knee arthroplasty
- Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
Who cannot join
- Patients with a current diagnosis of chronic pain
- Patients requiring narcotics for greater than one week prior to surgery
- Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
- Patient preference or need for spinal anesthesia rather than general anesthesia
- Patient planned for robotic surgical approach
Trial locations and contacts
1 site in 1 country.
About this study
The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.
Read the detailed description
Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.
- Being tested
- Pharmacogenomic (PGx), Review results
- Keywords
- pharmacogenomics, preoperative evaluation, perioperative opioid use
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic (PGx)Other
Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
Review resultsOther
Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenomic (PGx) guided | Experimental | Subjects will have Pharmacogenomic (PGx) testing preoperatively. The pharmacists will review results and make recommendations to the anesthesia and orthopedic teams for perioperative anesthesia and analgesia. The teams will use this information to drive clinical decisions as they see fit. Receives: Other: Pharmacogenomic (PGx); Other: Review results |
| Control | Active comparator | Subjects will undergo Pharmacogenomic (PGx) preoperatively but the results will be sealed until completion of treatment and clinicians will not have access to this information. These patients will undergo standard treatment dosing and medication selection. Receives: Other: Pharmacogenomic (PGx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Benefit of Analgesic Score (OBAS)
The overall benefit of analgesia score (OBAS) is a daily multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events (ORAEs), and patient satisfaction. It is a seven-item scale, with items ranging from( 0 = not at all) to(4 = very much). To calculate the Total OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Low score indicates high benefit.
Measured: baseline, 48 hours following PACU discharge
Secondary outcomes (3)
Change in prescription pattern for postoperative pain control.
Overall benefit of change in opioid prescription
Measured: baseline, 48 hours following PACU discharge
Change in Opioid requirements
Opioid doses will be recorded and converted into morphine equivalents.
Measured: baseline, 48 hours following PACU discharge
Changes in opioid use perioperatively based on pharmacogenomic testing
Opioid doses will be recorded and converted into morphine equivalents.
Measured: baseline, 48 hours following PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start12 Oct 2018
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Mayo 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly B. Kraus, Mayo Clinic
- Investigators
- Molly B Kraus, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579121
- Sponsor's protocol ID
- 17-006577
- Status last verified
- Jun 2022
- First submitted
- 25 Jun 2018
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraus MB, Bingham JS, Kekic A, Erickson C, Grilli CB, Seamans DP, Upjohn DP, Hentz JG, Clarke HD, Spangehl MJ. Does Preoperative Pharmacogenomic Testing of Patients Undergoing TKA Improve Postoperative Pain? A Randomized Trial. Clin Orthop Relat Res. 2024 Feb 1;482(2):291-300. doi: 10.1097/CORR.0000000000002767. Epub 2023 Aug 18.
PubMed 37594401
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
- ClinicalTrials.gov ID
- NCT03579121
- Acronym / sponsor ID
- 17-006577
- Keywords
- pharmacogenomics, preoperative evaluation, perioperative opioid use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 Jul 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 researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.
Detailed description
Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic (PGx) guided | Experimental | Other: Pharmacogenomic (PGx), Other: Review resultsSubjects will have Pharmacogenomic (PGx) testing preoperatively. The pharmacists will review results and make recommendations to the anesthesia and orthopedic teams for perioperative anesthesia and analgesia. The teams will use this information to drive clinical decisions as they see fit. |
| Control | Active comparator | Other: Pharmacogenomic (PGx)Subjects will undergo Pharmacogenomic (PGx) preoperatively but the results will be sealed until completion of treatment and clinicians will not have access to this information. These patients will undergo standard treatment dosing and medication selection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary total knee arthroplasty
- Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
Key exclusion criteria (5 listed)
- Patients with a current diagnosis of chronic pain
- Patients requiring narcotics for greater than one week prior to surgery
- Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
- Patient preference or need for spinal anesthesia rather than general anesthesia
- Patient planned for robotic surgical approach
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 |
|---|---|---|
| Pharmacogenomic (PGx)Administer a pharmacogenomics test (buccal swab) during the pre-operative setting | Other | Control, Pharmacogenomic (PGx) guided |
| Review resultsPharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions. | Other | Pharmacogenomic (PGx) guided |
Primary outcome
Change in Overall Benefit of Analgesic Score (OBAS)
Time frame: baseline, 48 hours following PACU discharge
The overall benefit of analgesia score (OBAS) is a daily multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events (ORAEs), and patient satisfaction. It is a seven-item scale, with items ranging from( 0 = not at all) to(4 = very much). To calculate the Total OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Low score indicates high benefit.
3 secondary outcomes
Change in prescription pattern for postoperative pain control.
Time frame: baseline, 48 hours following PACU discharge
Change in Opioid requirements
Time frame: baseline, 48 hours following PACU discharge
Changes in opioid use perioperatively based on pharmacogenomic testing
Time frame: baseline, 48 hours following PACU discharge
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 15 Jun 2022.
- Derived from this study: PubMed 37594401Kraus MB, Bingham JS, Kekic A, Erickson C, Grilli CB, Seamans DP, Upjohn DP, Hentz JG, Clarke HD, Spangehl MJ. Does Preoperative Pharmacogenomic Testing of Patients Undergoing TKA Improve Postoperative Pain? A Randomized Trial. Clin Orthop Relat Res. 2024 Feb 1;482(2):291-300. doi: 10.1097/CORR.0000000000002767. Epub 2023 Aug 18.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Postoperative Pain
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.
Molly B Kraus principal investigator
Mayo 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 Pharmacogenomic (PGx) and Review results in people with Perioperative/Postoperative Complications, run by Mayo 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 2 inclusion and 5 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 15 Jun 2022. 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 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?
Change in Overall Benefit of Analgesic Score (OBAS) (time frame: baseline, 48 hours following PACU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579121, which also lists 1 linked publication.
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 15 Jun 2022.