Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04360135
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: Acetaminophen; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
• Actual Study Start Date: May 6, 2020
• Actual Primary Completion Date: Mar 8, 2021
• Actual Study Completion Date: Mar 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preemptive acetominophen Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively	Drug: Acetaminophen; Preemptive acetaminophen the day before surgery
Placebo Comparator: Standard of care Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively	Drug: Placebo; Preemptive placebo the day before surgery

Outcome Measures

Primary Outcome Measures

1. Post-operative opioid use [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Holly Yettaw, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT04360135
• Other Study ID Numbers: 2019-10702
• First Posted: Apr 24, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen

Study Results

No Results Posted as of Aug 18, 2022