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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043704
First Posted: January 23, 2014
Last Update Posted: December 4, 2017
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.
Information provided by (Responsible Party):
TriHealth Inc.
  Purpose
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.

Condition Intervention Phase
Post Operative Pain Drug: IV Acetaminophen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Post Operative Pain [ Time Frame: 24 hours ]
    Post operative pain will be assessed 18 and 24 hours after surgery and immediately prior to discharge. Pain will be self reported by patients using a 10cm visual analog scale (VAS). At each time point a pain score will be collected for pain at rest and pain with ambulation or an action symbolizing ambulation (i.e. coughing).

  • 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 Outcome Measures:
  • Narcotic associated side effects [ Time Frame: 24 hours ]
    The incidence of known narcotic associated side effects will be recorded, including: nausea, emesis, itching, headache, insomnia, rash/hives, shortness of breath, respiratory depression, and urinary retention.

  • Time to first rescue narcotic [ Time Frame: 24 hours ]
    The time from the end of surgery to the time any IV narcotic is given.


Other Outcome Measures:
  • Time to ambulation [ Time Frame: 24 hours ]
    Length of time from the end of surgery to the time of ambulation.

  • Time to first flatus/bowel movement [ Time Frame: 24 hours ]
    Length of time from the end of surgery to the time of first flatus or bowel movement.


Enrollment: 100
Study Start Date: January 2014
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.
Drug: IV Acetaminophen
Details covered in arm description.
Other Name: Ofirmev
Placebo Comparator: Saline
Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.
Drug: IV Acetaminophen
Details covered in arm description.
Other Name: Ofirmev

Detailed Description:
see brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02043704


Locations
United States, Ohio
TriHealth - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Catrina Crisp, MD, MSc TriHealth Inc.
  More Information

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02043704     History of Changes
Other Study ID Numbers: 13072
First Submitted: January 21, 2014
First Posted: January 23, 2014
Last Update Posted: December 4, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by TriHealth Inc.:
IV Acetaminophen
Vaginal Reconstruction
Pain, Postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics