IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

What Was Tested

This registered phase 4 trial tested Oxytocin.

This double-blinded, placebo-control trial clinical trial aims to investigate the effect of IV oxytocin infusion on peri-operative opioid consumption following a minimally invasive hysterectomy under general anesthesia.

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

The registry classes the interventions as drug.

More on the Plan

For patients who do not complete the survey, a phone call from a study staff member will be performed to complete all questions not completed with the online form.

Who Took Part

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

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

Examples of who could join: Women the age of 18-65 years old undergoing elective, minimally invasive hysterectomy under general anesthesia.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: american society of anesthesiology (asa) physical status classification system score of 4 or greater; additional surgical components including but not limited to: minor laparotomy, omentectomy, cystectomy, and lymph node dissection; allergies to any study medication: acetaminophen, ketorolac, hydromorphone, oxycodone, fentanyl, gabapentin, pregabalin.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-06-01 with completion listed for 2024-06.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total opioids consumption (time frame: 3 days).

It also tracked 5 secondary outcomes, for example Post Operative Pain scores, Anxiety score, Quality of Recovery Score, Catastrophizing Scale and Patient-rated Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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