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RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Pain

Intervention: IV Acetaminophen (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: TriHealth Inc.

Official(s) and/or principal investigator(s):
Catrina Crisp, MD, MSc, Principal Investigator, Affiliation: TriHealth Inc.

Overall contact:
Catrina Crisp, MD, MSc, Phone: 513-819-0798, Email: catrina_crisp@trihealth.com


This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.

Clinical Details

Official title: The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Post Operative Pain

Total amount of narcotic consumption in the first 24 hours post surgery

Secondary outcome:

Narcotic associated side effects

Time to first rescue narcotic

Detailed description: see brief summary


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.


Inclusion Criteria:

- Women between the ages of 18 and 70 years

- Patients of the Division of Urogynecology at Good Samaritan and Bethesda North

Hospitals in Cincinnati, Ohio

- Scheduled to undergo major vaginal reconstruction

- Must undergo total vaginal hysterectomy, anterior repair, posterior repair,

enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion. Exclusion Criteria:

- Allergy to acetaminophen

- Liver disease (chronic or active)

- Chronic alcohol use (>1 drink/day)

- Bleeding diathesis

- Renal disease

- Opiate dependent or daily use

- History of chronic pain

- Mental or cognitive disorder preventing patient to accurately verbalize pain levels

- Undergoing abdominal or laparoscopic procedures at the time of surgery

- Allergy to hydromorphone

- Surgery is not performed under general anesthesia

Locations and Contacts

Catrina Crisp, MD, MSc, Phone: 513-819-0798, Email: catrina_crisp@trihealth.com

TriHealth - Good Samaritan and Bethesda North Hospitals, Cincinnati, Ohio 45220, United States; Recruiting
Michaela Eschenbacher, MPH, Phone: 513-862-2341, Email: michaela_eschenbacher@trihealth.com
Additional Information

Starting date: January 2014
Last updated: February 5, 2015

Page last updated: August 23, 2015

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