search
Back to results

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Primary Purpose

Post Operative Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Placebo
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preemptive acetominophen

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-operative opioid use
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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2020
Last Updated
August 16, 2022
Sponsor
Montefiore Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04360135
Brief Title
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
Official Title
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was closed on 3/8/2021 as per final progress report issued by the IRB on 3/12/2021. No subjects were enrolled in the study following approval. Status changed to "Withdrawn (No Participants Enrolled)" accordingly.
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preemptive acetominophen
Arm Type
Experimental
Arm Description
Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Preemptive acetaminophen the day before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Preemptive placebo the day before surgery
Primary Outcome Measure Information:
Title
Post-operative opioid use
Description
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.
Time Frame
4 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Yettaw, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

We'll reach out to this number within 24 hrs