Study 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 Status changed to "Withdrawn (No Participants Enrolled)" accordingly.
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedAugust 18, 2022
August 1, 2022
10 months
April 17, 2020
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 hours
Study Arms (2)
Preemptive acetominophen
EXPERIMENTALAcetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
Standard of care
PLACEBO COMPARATORPlacebo the day before surgery and acetaminophen 30-60 minutes preoperatively
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing minimally invasive hysterectomy for benign indications
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Yettaw, MD
Montefiore Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 24, 2020
Study Start
May 6, 2020
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
August 18, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share