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Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03011307
Collaborator
(none)
94
Enrollment
1
Location
2
Arms
56
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oxytocin

Oxytocin 100 micrograms administered intrathecally

Drug: Oxytocin
spinal injection of oxytocin
Placebo Comparator: Placebos

Placebo injection administered intrathecally

Drug: Placebos
spinal injection of placebo

Outcome Measures

Primary Outcome Measures

  1. Rate of patient reported pain resolution (Slope), over time, as assessed using growth curve modeling [60 days postoperative]

    Daily pain intensity report for each subject will be fit using growth curve model and the intercept (modeled initial pain) and slope of change determined

  2. Initial pain intensity (intercept) as assessed using growth curve modeling [60 days postoperative]

    Daily pain intensity report for each subject will be fit using growth curve model and the intercept (modeled initial pain) and slope of change determined

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: James C Eisenach, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03011307
Other Study ID Numbers:
  • IRB00036246
First Posted:
Jan 5, 2017
Last Update Posted:
Jan 24, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative
Oxytocin

Study Results

No Results Posted as of Jan 24, 2022