Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Recruiting
Phase 2Interventional Study
Postoperative Pain
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
152 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
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This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Ages 18-65 years old
* ASA category 1-3
* Scheduled to undergo minimally invasive hysterectomy
* No documented allergy to oxytocin
Exclusion Criteria:
* American Society of Anesthesiologists (ASA) group 4 or greater
* Age \>65 years old
* Additional surgical procedures inclu…
Inclusion Criteria:
* Ages 18-65 years old
* ASA category 1-3
* Scheduled to undergo minimally invasive hysterectomy
* No documented allergy to oxytocin
Exclusion Criteria:
* 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.
* Active opioid prescription of the equivalent of oxycodone \>10 mg /day
* Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone)
* Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone.
* Epidural/Regional anesthesia for intra-operative or post-operative pain.
* Inability to understand the questionnaires
* Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL \>500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications
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