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Completed

NCT Number: NCT02043704

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

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

TriHealth - Good Samaritan and Bethesda North Hospitals

Cincinnati, Ohio, 45220, United States

About this study

see brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen

Drug

Details covered in arm description.

Other names: Ofirmev

Primary outcomes

  1. Pain While Active - 18 hr

    Time frame: 18 hours

    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.

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

    Time frame: 24 hours

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

Secondary outcomes

  1. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.

  2. Time to First Rescue Narcotic

    Time frame: 24 hours

    The time from the end of surgery to the time any IV narcotic is given.

  3. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for itching.

  4. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for headache.

  5. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for insomnia.

  6. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for rash/hives.

  7. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for shortness of breath.

  8. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for respiratory depression.

  9. Narcotic Associated Side Effects

    Time frame: 24 hours

    The incidence of known narcotic associated side effects will be recorded for urinary retention.

  10. Time to Ambulation

    Time frame: 1800 minutes

    Length of time from the end of surgery to the time of ambulation.

Other outcomes

  1. Time to First Flatus/Bowel Movement

    Time frame: 9000 minutes

    Length of time from the end of surgery to the time of first flatus or bowel movement.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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