Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-12

Study Completion Date

2021-08-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin

Oxytocin 100 micrograms administered intrathecally

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

spinal injection of oxytocin

Placebos

Placebo injection administered intrathecally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

spinal injection of placebo

Interventions

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Oxytocin

spinal injection of oxytocin

Intervention Type DRUG

Placebo

spinal injection of placebo

Intervention Type DRUG

Other Intervention Names

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Pitocin Saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No