Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579121
Other study ID # 17-006577
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2018
Est. completion date April 1, 2022

Study information

Verified date June 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date April 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pharmacogenomic (PGx)
Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
Review results
Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.

Locations

Country Name City State
United States Mayo Clinic in Arizona Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 48 hours following PACU discharge
Secondary Change in prescription pattern for postoperative pain control. Overall benefit of change in opioid prescription baseline, 48 hours following PACU discharge
Secondary Change in Opioid requirements Opioid doses will be recorded and converted into morphine equivalents. baseline, 48 hours following PACU discharge
Secondary Changes in opioid use perioperatively based on pharmacogenomic testing Opioid doses will be recorded and converted into morphine equivalents. baseline, 48 hours following PACU discharge
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Recruiting NCT03740438 - Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Recruiting NCT05594199 - Feasibility of a Virtual Smoking Cessation Program N/A
Completed NCT00538499 - Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery N/A
Recruiting NCT01690338 - A Study of Residual Curarization Incidence in China Phase 4
Recruiting NCT01110798 - J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor N/A
Completed NCT00859157 - Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer N/A
Withdrawn NCT03531268 - Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing N/A
Recruiting NCT04356638 - a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients Phase 3
Completed NCT03899441 - Multimedia Aid Gynecologic Counseling and Consent N/A
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Completed NCT01672892 - Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer Phase 3
Completed NCT01510652 - More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges N/A
Completed NCT01680367 - Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery N/A
Active, not recruiting NCT00005600 - Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer N/A
Recruiting NCT05743673 - SHAPE Test for Preoperative Risk Stratification
Recruiting NCT03197792 - Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy N/A

External Links