Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Phase 2

Withdrawn

• Conditions: Post Operative Pain
• Interventions: Drug: Acetaminophen; Drug: Placebo

• Registration Number: NCT04360135
• Lead Sponsor: Montefiore Medical Center

Brief Summary

This study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. Patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. The morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. The investigators will examine whether there is a difference in post operative pain between the two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-05-06
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Undergoing minimally invasive hysterectomy for benign indications

Exclusion Criteria

• acetaminophen allergy
• liver disease
• kidney disease
• consume >3 alcoholic beverages per day
• weigh <50 kilograms
• report daily opiate use
• contraindication to acetaminophen
• used acetaminophen within 24 hours of surgery
• undergoing a concomitant pelvic reconstructive procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preemptive acetominophen	Acetaminophen	Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
Standard of care	Placebo	Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively

Primary Outcome Measures

Name	Time	Method
Post-operative opioid use	4 hours	The total amount of opiate consumption in the immediate postoperative period will be recorded. Per standard protocol, patient's will be ordered for pain medication to receive on an as needed basis. The amount of both oral and IV opioids consumed by the patient will be converted to total morphine equivalents. As such, post operative opioid use will be used as a proxy for degree of post operative pain.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States