Intravenous Oxytocin for Recovery After Total Hip Replacement

DR
RC
Overseen ByRegina Curry, R.N.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an IV treatment with oxytocin (a hormone given through an intravenous drip) can speed recovery after hip replacement surgery by increasing daily steps over eight weeks. The study compares oxytocin to a placebo to determine which is more effective. It seeks participants scheduled for a first-time hip replacement who are in overall good health. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including thiazide diuretics, loop diuretics, lithium, and some antidepressants like SSRIs and MAOIs. If you're on any of these, you may need to stop them before participating.

Is there any evidence suggesting that intravenous oxytocin is likely to be safe for humans?

Research has shown that intravenous oxytocin is generally safe for patients undergoing hip surgery. Studies have found that oxytocin, compared to a saltwater solution, does not increase the risk of low blood pressure or the need for medication to raise blood pressure. This suggests the treatment likely doesn't cause major heart or blood pressure issues. While these results are encouraging, it's important to note that the treatment is still under investigation for recovery after hip replacement surgery. Ongoing studies will provide more detailed safety information.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for recovery after total hip replacement, which typically focus on pain management and physical therapy, intravenous oxytocin offers a novel approach by potentially enhancing recovery through its unique mechanism of action. Oxytocin is a hormone known for its role in social bonding and childbirth, but it also has anti-inflammatory properties that could help reduce post-surgical inflammation and promote healing. Researchers are excited about this treatment because it targets recovery in a holistic way, potentially speeding up the process and improving overall outcomes by addressing both physical and inflammatory responses to surgery.

What evidence suggests that intravenous oxytocin might be an effective treatment for recovery after total hip replacement?

Research suggests that administering oxytocin through an IV might speed up recovery after hip surgery. In this trial, participants will receive either oxytocin or a placebo. Some studies have found that oxytocin can reduce pain and disability more quickly after surgery. For instance, patients who received oxytocin after hip replacement reported returning to their daily activities and moving around sooner. Although the evidence isn't definitive yet, these early results indicate that oxytocin could help patients resume their normal routines more quickly after surgery.23456

Who Is on the Research Team?

DR

Douglas Ririe, M.D.

Principal Investigator

Wake Forest University School of Meidcine

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who are scheduled for their first hip replacement surgery on one side, are generally healthy, can read and write English, have a stable home, and are willing to follow study procedures.

Inclusion Criteria

I am between 18 and 75 years old.
I am scheduled for my first total hip replacement on one hip.
* Able to read and write English and have a stable residence.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous oxytocin or placebo to assess recovery speed after Total Hip Arthroplasty

8 weeks
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Intravenous Oxytocin

Trial Overview

The study compares giving oxytocin through an IV versus a placebo during the time around hip replacement surgery to see if it helps people recover faster by tracking daily steps over about two months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: OxytocinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Randomized controlled trial of intrathecal oxytocin on speed of ...

Oxytocin signaling may speed recovery from pain and disability after surgery. Quicker recovery from pain after surgery has been noted in multiple studies of ...

Efficacy of Intrathecal Oxytocin to Speed Recovery After ...

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. Detailed ...

Hypotension duration and vasopressor requirements ...

Compared to saline control, intrathecal oxytocin, 100 μg did not increase the duration of hypotension or vasopressor requirements in patients during total hip ...

Intravenous Oxytocin for Recovery After Total Hip ...

The purpose of this study is to test whether perioperative intravenous (IV) oxytocin compared to placebo results in faster recovery in disability as ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36448974/

Randomized controlled trial of intrathecal oxytocin on speed of ...

Intrathecal oxytocin before hip replacement surgery does not speed recovery from worst daily pain. Secondary analyses suggest that further ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37356196/

Secondary analysis of a randomized controlled trial - PubMed

Compared to saline control, intrathecal oxytocin, 100 μg did not increase the duration of hypotension or vasopressor requirements in patients during total hip ...