Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

NCT03011307 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00036246
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept

  Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Values represent an intercept of modeled worst daily pain on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.

  The first day after hospital discharge

• Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope

  Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Slope is defined as change in pain . Values represent the slope of modeled worst daily pain (0-10 scale as described above) divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.

  Postoperative Day 1 through Postoperative Day 60

Secondary Outcomes (9)

• Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept

  The first day after hospital discharge

• Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope

  Postoperative Day 1 through Postoperative Day 60

• Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Intercept

  Modeled WHODAS 2.0 one week after hospital discharge

• Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Slope

  Postoperative Day 7 through Postoperative Day 56

• Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept

  The first day after hospital discharge

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin 100 micrograms administered intrathecally

Drug: Oxytocin

Placebos

PLACEBO COMPARATOR

Placebo injection administered intrathecally

Drug: Placebo

Interventions

Oxytocin DRUG

spinal injection of oxytocin

Also known as: Pitocin

Oxytocin

Placebo DRUG

spinal injection of placebo

Also known as: Saline

Placebos

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The trial was terminated early because of depletion of funding. Power analysis was based on 120 subjects and only 90 were studied before termination of funding .

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University School of Medicine

eisenach@wakehealth.edu

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 5, 2017
• Study Start: January 12, 2017
• Primary Completion: October 23, 2020
• Study Completion: August 11, 2021
• Last Updated: November 23, 2022
• Results First Posted: November 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)