Clinical trial NCT03011307: Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
Official title: Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of intrathecal oxytocin on speed of reduction in pain for the first 60 days after hip surgery.

Detailed description: This is a single-center, NIH funded clinical study at Wake Forest Baptist Medical Center. The investigators anticipate that intrathecal oxytocin will speed recovery from pain after major surgery (hip arthroplasty). For this study, the investigators will use a randomized, controlled and blinded study of intrathecal oxytocin in patients scheduled for hip arthroplasty, with primary outcome being the slope of change in pain over the first 60 days following surgery, using growth curve modeling and a ln(time) function.

Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral, primary total hip replacement
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Pregnancy
* Currently Workman's Comp litigation related to hip replacement
* Taking greater than 100 milligrams of morphine (or equivalent)
* Suffering from a psychotic disorder or a recent psychiatric hospitalization

Primary outcomes:
measure: Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept
timeFrame: The first day after hospital discharge
measure: Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope
timeFrame: Postoperative Day 1 through Postoperative Day 60
Secondary outcomes:
measure: Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept
timeFrame: The first day after hospital discharge
measure: Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope
timeFrame: Postoperative Day 1 through Postoperative Day 60
measure: Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Intercept
timeFrame: Modeled WHODAS 2.0 one week after hospital discharge
measure: Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Slope
timeFrame: Postoperative Day 7 through Postoperative Day 56
measure: Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept
timeFrame: The first day after hospital discharge
measure: Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Slope
timeFrame: Postoperative Day 1 through Postoperative Day 60
measure: Iowa Gambling Task
timeFrame: Preoperative, 2 months after surgery
measure: Wisconsin Card Sort Task
timeFrame: Preoperative, 2 months after surgery
measure: Tampa Scale of Kinesiophobia
timeFrame: Preoperative, 2 months after surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C Eisenach, MD
role: PRINCIPAL_INVESTIGATOR
References: