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

Phase 4CompletedNCT02043704

TriHealth Inc.100 enrolled

Overview

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.

see brief summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Post Operative Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain While Active - 18 hr

Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.

Time frame: 18 hours

Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery

Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.

Time frame: 24 hours