- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360135
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
August 16, 2022 updated by: Montefiore Medical Center
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Preemptive acetominophen
Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
|
Preemptive acetaminophen the day before surgery
|
Placebo Comparator: Standard of care
Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively
|
Preemptive placebo the day before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Holly Yettaw, MD, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2020
Primary Completion (Actual)
March 8, 2021
Study Completion (Actual)
March 8, 2021
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
August 18, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-10702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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