Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03011307

IRB00036246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

126 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

Oxytocin 100 micrograms administered intrathecally

Treatment:

Drug: Oxytocin

Placebos

Placebo Comparator group

Description:

Placebo injection administered intrathecally

Treatment:

Drug: Placebo