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NCT04360135 Clinical Trial

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Post Operative Pain Clinical Trial

Official title:
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04360135
Other study ID # 2019-10702
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
Start date May 6, 2020
Est. completion date March 8, 2021

Study information
Verified date August 2022
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 8, 2021
Est. primary completion date March 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Acetaminophen
Preemptive acetaminophen the day before surgery
• Placebo
Preemptive placebo the day before surgery

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (1)
Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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