Total Hip Arthroplasty
Conditions
Keywords
Intravenous (IV) oxytocin, Postoperative pain, Disability
Brief summary
The purpose of this study is to test whether perioperative intravenous (IV) oxytocin compared to placebo results in faster recovery in disability as measured by daily steps over 56 days after Total Hip Arthroplasty (THA).
Detailed description
This is a single center, NIH funded clinical study at Atrium Health Wake Forest Baptist Medical Center. The investigators will utilize a triple-masked, parallel group, randomized design to compare intravenous (IV) oxytocin to placebo to determine IV oxytocin's actions on speed of recovery from physical disability and postoperative pain after Total Hip Arthroplasty (THA).
Interventions
DRUGintravenous administration of oxytocin
Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.
DRUGPlacebo
Saline will be administered intravenously over a period of 45 minutes
Sponsors
Wake Forest University Health Sciences
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female \> 18 and ≤75 years of age * Scheduled for unilateral, primary total hip arthroplasty surgery * Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3 * Willing to perform the study procedures * Able to read and write English and have a stable residence.
Exclusion criteria
* Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection) * Latex allergy * Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the participant at increased risk (e.g., active gynecologic disease in which increased tone would be detrimental such as uterine fibroids with ongoing bleeding) * Women who are pregnant, are currently nursing or lactating, or have been pregnant within 2 years * Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval. * Past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective Serotonin Reuptake Inhibitors (SSRI's), Monoamine oxidase inhibitors (MAOIs), or the recreational drug ecstasy. * Inability to complete questionnaires * Litigation or workers compensation related to their joint surgery * Taking \> 100 mg morphine equivalents/day * Suffering from a psychotic disorder or a recent psychiatric hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modeled daily steps trajectory | 56 days after surgery | Individual trajectories, adjusted for prognostic covariates, of daily steps will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is in units of steps on the first post-discharge day with the lower number of steps indicating more disability and the slope is in units of logarithm of steps per day with the lower number indicating slower recovery from disability - Key models often classify adults into sedentary (\<5,000 steps), low active (5,000-7,499), somewhat active (7,500-9,999), or active (≥10,000) trajectories. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modeled pain intensity trajectory | 56 days after surgery | Description: Individual trajectories, adjusted for prognostic covariates, of worst daily pain intensity scores (0-10 scale) from daily diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is pain score on the first post-discharge day with the higher score indicating more pain and the slope is in units of logarithm of pain score per day with the lower number indicating slower recovery from pain |
| Modeled disability assessments | 56 days after surgery | Individual trajectories, adjusted for prognostic covariates, of World Health Organization Disability Assessment Schedule (WHODAS) 2.0 scores from weekly diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. Each item in the WHODAS 2.0 questionnaire is rated on a 5-point scale from 0 (none) to 4 (extreme or cannot do). Total Range: 0-48 (Raw sum), where 0 is the minimum and 48 is maximum disability. A higher score signifies a greater level of disability. |
| Modeled opioid dosing trajectory | 56 days after surgery | Individual trajectories, adjusted for prognostic covariates, of daily opioid dose in milligrams of morphine equivalents from daily diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is in opioid dose on the first post-discharge day and the slope is in units of logarithm of opioid dose per day with the lower number indicating slower quicker reduction in opioid dose over time. |
| Modeled opioid cessation trajectory | 56 days after surgery | : Individual trajectories, adjusted for prognostic covariates, of time to opioid cessation from daily diaries, in which each day is scored as taking opioids or not taking opioids. Opioid cessation for each individual is the last day they took an opioid. The trajectory for the likelihood of taking opioids will be determined using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDouglas Ririe, M.D.
Wake Forest University School of Meidcine
Outcome results
None listed