Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had two arms (groups): Medication (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm.

Participants, surgeons, clinicians, and raters will be blinded with respect to treatment assignments.

Patients will be pre-screened for inclusion and exclusion criteria.

Subsequently, they will be recruited for participation in this study by phone/ MGB Zoom and will be consented by electronic consent.

Who Took Part

Enrollment: 152 planned participants were the target.

It was open to women only aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Ages 18-65 years old. ASA category 1-3. Scheduled to undergo minimally invasive hysterectomy. No documented allergy to oxytocin.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: american society of anesthesiologists (asa) group 4 or greater; age \>65 years old; additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and/or ablation of endometriosis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2025-06-01 with completion listed for 2027-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Post-operative pain (time frame: Between 2-4 hours after surgery completion (in the PACU)).

It also tracked 14 secondary outcomes, for example Perioperative opioid consumption, POD1 Opioid consumption, POD2 Opioid consumption, POD3 Opioid consumption, PACU satisfaction scores and POD1 satisfaction scores.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 152 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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