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Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04360135
Enrollment
0
Registered
2020-04-24
Start date
2020-05-06
Completion date
2021-03-08
Last updated
2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

DRUGAcetaminophen

Preemptive acetaminophen the day before surgery

DRUGPlacebo

Preemptive placebo the day before surgery

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative opioid use4 hoursThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026