Henry Ford Health System
Detroit, Michigan, 48202, United States
NCT Number: NCT03818932
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of anterior cruciate ligament reconstruction: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Detroit, Michigan, 48202, United States
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring anterior cruciate ligament reconstruction will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by Visual Analogue Scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria:
Inclusion criteria
Exclusion criteria
Post-Operative Non Opioid Pain Protocol
Other names: Celebrex
Traditionally used narcotic pain protocol
Other names: Norco
Post-Operative Non Opioid Pain Protocol
Other names: Toradol
Post-Operative Non Opioid Pain Protocol
Other names: Neurotin
Post-Operative Non Opioid Pain Protocol
Other names: Tylenol
Post-Operative Non Opioid Pain Protocol
Other names: Valium
Time frame: 10 days post-operatively
Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale is a validated measure for pain where 0 is no pain and 10 is the worst pain. Average daily pain was calculated for each patient. Higher values portend worse control.
Time frame: From preoperative visit to 10 days post-operatively
Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function.
Henry Ford Health System
Other
Traditional vs. Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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