Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had two arms (groups): Oxytocin (experimental) and Placebos (placebo comparator).

Placebo injection administered intrathecally.

The registry classes the interventions as drug.

More on the Plan

The investigators anticipate that intrathecal oxytocin will speed recovery from pain after major surgery (hip arthroplasty).

Who Took Part

126 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Scheduled for unilateral, primary total hip replacement. American Society of Anesthesiologists physical status 1-3.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-01-12 with completion listed for 2020-10-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept (time frame: The first day after hospital discharge). Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope (time frame: Postoperative Day 1 through Postoperative Day 60).

It also tracked 9 secondary outcomes, for example Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept, Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope, Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept, Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Slope, Iowa Gambling Task and Wisconsin Card Sort Task.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 126 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.