Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Post Operative Pain

Treatments: Drug: Acetaminophen; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04360135

2019-10702

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Preemptive acetominophen

Experimental group

Description:

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

Treatment:

Drug: Acetaminophen

Standard of care

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo