Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

NCT ID: NCT04360135

Last Updated: 2022-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2021-03-08

Brief Summary

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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

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Preemptive acetominophen

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

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Preemptive acetaminophen the day before surgery

Standard of care

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Preemptive placebo the day before surgery

Interventions

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Acetaminophen

Preemptive acetaminophen the day before surgery

Intervention Type DRUG

Placebo

Preemptive placebo the day before surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Yettaw, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2019-10702

Identifier Type: -

Identifier Source: org_study_id

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