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Completed

NCT Number: NCT02155738

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

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Key information

Conditions

Pelvic Organ Prolapse Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Prolapse Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Magee-Womens Hospital of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women ≥ 18 years of age
  • scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
  • women anticipated to have a hospital stay ≥24 hours

Exclusion criteria

  • allergy/intolerance to acetaminophen
  • hepatic dysfunction
  • significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

Treatment and study plan

IV acetaminophen

Drug

Other names: Ofirmev

IV normal saline

Drug

IV normal saline

Other names: placebo

Primary outcomes

  1. Change From Baseline in Postoperative Pain

    Time frame: 24 hours

    VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.

    For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.

    The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.

  2. Cumulative Narcotic Consumption Over the First 24 Hours

    Time frame: First 24 hours

    Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.

Secondary outcomes

  1. Interference of Pain With Physical, Mental and Social Activities

    Time frame: 1 week

    Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.

    This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.

    A higher PROMIS score indicates more 'hurt' or pain.

Sponsors and collaborators

Lead sponsor

Halina M Zyczynski, MD

Other

Registry information

Official study title

The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2014
Registry last updated
Nov 19, 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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