Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02155738
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Halina M Zyczynski, MD, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Drug: IV Acetaminophen Drug: IV normal saline Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Drug: IV normal saline
IV normal saline
Other Name: placebo

Experimental: IV Acetaminophen
100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Drug: IV Acetaminophen
Other Name: Ofirmev




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155738


Locations
Layout table for location information
United States, Pennsylvania
Magee-Womens Hospital of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Halina M Zyczynski, MD
  Study Documents (Full-Text)

Documents provided by Halina M Zyczynski, MD, University of Pittsburgh:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Halina M Zyczynski, MD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02155738     History of Changes
Other Study ID Numbers: PFD-C-14-009
First Posted: June 4, 2014    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: October 2018
Keywords provided by Halina M Zyczynski, MD, University of Pittsburgh:
IV acetaminophen
Postoperative pain
Pelvic organ prolapse surgery
Pelvic organ prolapse repair
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Pain, Postoperative
Prolapse
Pelvic Organ Prolapse
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics