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Clinical Trials/NCT04360135
NCT04360135
Withdrawn
Phase 2

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial

Montefiore Medical Center1 site in 1 countryMay 6, 2020

Overview

Phase
Phase 2
Intervention
Acetaminophen
Conditions
Post Operative Pain
Sponsor
Montefiore Medical Center
Locations
1
Primary Endpoint
Post-operative opioid use
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2020
End Date
March 8, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Preemptive acetominophen

Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively

Intervention: Acetaminophen

Standard of care

Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively

Intervention: Placebo

Outcomes

Primary Outcomes

Post-operative opioid use

Time Frame: 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.

Study Sites (1)

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