Oxytocin for Postoperative Pain

Overseen By Rusul I Al-Ani

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Opioids, Naltrexone, Suboxone

Disqualifiers: Age >65, ASA 4, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: Intraoperative period (approximately 2-4 hours)

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether oxytocin, a hormone known for its role in childbirth, can reduce pain and the need for opioids after a minimally invasive hysterectomy. Participants will receive either an oxytocin infusion or a placebo (a substance with no active effect) to compare results. The main aim is to determine if oxytocin can make recovery more comfortable by reducing opioid use. The trial seeks women scheduled for a minimally invasive hysterectomy who do not have allergies to oxytocin or certain medications and are not currently using opioids regularly. As a Phase 2 trial, this research measures how well oxytocin works in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have an active opioid prescription over a certain amount or if you are using certain medications for opioid use disorder.

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

Research has shown that oxytocin is generally safe for humans. In one study where patients inhaled oxytocin, participants reported no negative effects, and it did not affect heart or blood vessel function. Another study found that using a low dose of oxytocin after cesarean sections reduced the need for other pain medications without causing additional side effects.

While some studies suggest oxytocin can help with pain relief, a review of several studies found it did not significantly reduce pain intensity. However, overall research indicates that oxytocin is well-tolerated and does not cause serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional pain medications such as opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), which primarily work by blocking pain signals, oxytocin is unique because it taps into the body's natural hormone system to potentially reduce pain and promote healing. Oxytocin is often referred to as the "love hormone" and is naturally involved in processes like childbirth and bonding, but researchers believe it may also modulate pain perception in a safer way. This new approach could mean fewer side effects and a reduced risk of dependency compared to conventional pain relief options. Researchers are excited about oxytocin’s potential to offer a novel, hormone-based solution for managing postoperative pain.

What evidence suggests that oxytocin might be an effective treatment for postoperative pain?

Research shows that oxytocin might reduce the need for painkillers after surgery. One study found that patients who inhaled oxytocin experienced less pain and required fewer opioids, which are strong pain-relief drugs. However, a review of several studies found no significant decrease in pain levels with oxytocin. Another study indicated that while oxytocin didn't reduce the worst pain felt each day, it seemed to aid faster recovery and reduced opioid use. Additionally, using a low dose of oxytocin after cesarean sections lowered the need for pain medicine without increasing side effects. These findings suggest that oxytocin could help manage postoperative pain, but results have been mixed. In this trial, one group will receive an oxytocin infusion, while another group will receive a placebo infusion to compare effects on postoperative pain management. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with an ASA category of 1-3 who are scheduled to have a minimally invasive hysterectomy and do not have any known allergies to oxytocin. It's designed for those looking to manage postoperative pain.

Inclusion Criteria

My health is good to moderately impaired.

I am scheduled for a minimally invasive hysterectomy.

I am not allergic to oxytocin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or phone)

Pre-operative

Participants are pre-screened and consented, and baseline questionnaires are completed

1 week

1 visit (virtual)

Treatment

Participants receive either oxytocin or placebo infusion during surgery

Intraoperative period (approximately 2-4 hours)

1 visit (in-person, during surgery)

Post-operative

Participants are monitored in the PACU for pain and vital signs, and complete a pain questionnaire

0-4 hours post-surgery

1 visit (in-person, PACU)

Follow-up

Participants are monitored for pain and opioid consumption up to 3 months post-op

3 months

Online surveys on POD1, POD2, POD3, and follow-up until 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin

Trial Overview

The study is testing the effectiveness of IV oxytocin compared to a placebo in reducing the need for opioids and alleviating pain after minimally invasive hysterectomy surgery, using a randomized, double-blinded approach.

How Is the Trial Designed?

Group I: Medication Active Control 1 Intervention

one group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline .

Group II: Placebo Placebo Group 1 Intervention

one group will receive 500 ml of 0.9% normal saline

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2405603025000342

Efficacy of perioperative inhalational oxytocin on ...

Inhalational oxytocin effectively reduced postoperative pain and opioid requirements without affecting hemodynamic stability or causing adverse events.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10187080/

Evaluating the efficacy of oxytocin for pain management

Meta-analysis of three studies indicated that exogenous oxytocin administration did not result in a significant reduction in pain intensity ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06483659

Intravenous Oxytocin for Post Operative Pain After ...

This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid ...

4.

rapm.bmj.com

rapm.bmj.com/content/50/Suppl_1/A412

FT40 Role of oxytocin

The oxytocin group did not experience a decrease in worst daily pain, but they did have faster recovery and reduced opioid use.(Eisenach et al., 2023b) ...

5.

brieflands.com

brieflands.com/journals/jid/articles/164632

A Randomized Clinical Trial on the Analgesic Effects of ...

Conclusions: Low-dose oxytocin infusion following cesarean section under spinal anesthesia effectively reduces analgesic requests while presenting comparable ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10106358/

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

We hypothesized that intrathecal injection of oxytocin would speed recovery from pain and disability after major surgery.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05608070

IV Oxytocin for Post Operative Pain After Minimally Invasive ...

This double-blinded, placebo-control trial clinical trial aims to investigate the effect of IV oxytocin infusion on peri-operative opioid consumption ...