Efficacy of IV Acetaminophen for Pain Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Aultman Health Foundation
Sponsor:
Information provided by (Responsible Party):
Aultman Health Foundation
ClinicalTrials.gov Identifier:
NCT02028715
First received: January 2, 2014
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, cost effectiveness, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more cost effective postoperative pain management approach.


Condition Intervention Phase
Post-operative Pain
Drug: Placebo (normal saline)
Drug: IV acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay.

Resource links provided by NLM:


Further study details as provided by Aultman Health Foundation:

Primary Outcome Measures:
  • Amount of opioid rescue needed [ Time Frame: First 48 hours after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to return of bowel function (passage of flatus) [ Time Frame: Duration of hospital stay; an expected average of 5 days ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 24 h post-operation; 48 h post-operation; time of discharge ] [ Designated as safety issue: No ]
    Subjects will rate their overall satisfaction with study treatment and treatment associated adverse side effects (TAAEs) (e.g. nausea, vomiting, bloating, constipation) at 24 hours, 48 hours, and again at time of discharge using a categorical scale: 1 poor; 2 fair; 3 good; 4 excellent.

  • Cost Effectiveness [ Time Frame: 30-day post-operation ] [ Designated as safety issue: No ]
    Total cost of hospital stay will be compared between the two study groups. Cost analysis will be limited to price of pain medications as well as those used to treat TAAEs (e.g. ondansetron, promethazine, simethicone, bisacodyl); diagnostic or laboratory studies used to evaluate potential TAAEs (e.g. abdominal radiograph to evaluate for possible ileus, comprehensive metabolic panel); and base daily hospitalization cost


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Drug: Placebo (normal saline)
Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Active Comparator: Experimental (IV Acetaminophen)
Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Drug: IV acetaminophen
IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Other Name: Ofirmev

Detailed Description:

This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:

  1. Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
  2. Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; cost effectiveness; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

Exclusion Criteria:

  • Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
  • Patients with baseline CrCl <30.
  • Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
  • Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
  • Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
  • Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
  • Patients that have required regular opioid intake for the 7 days preceding surgery.
  • NSAIDs within 8 hours of surgery.
  • Chronic steroid use with the exception of low-dose inhaled steroid formulations.
  • Chronic alcohol or drug abuse.
  • Patients currently pregnant.
  • Patients unable to provide informed consent.
  • Age >85
  • Any physical, medical, and mental condition that would make participation in the study inadvisable.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028715

Locations
United States, Ohio
Aultman Health Foundation Recruiting
Canton, Ohio, United States, 44720
Contact: Laura K Randolph, DO; MS    330-363-6214    LRandolph@aultman.com   
Principal Investigator: Laura K Randolph, DO; MS         
Sub-Investigator: Jennifer L. Parker, DO         
Sub-Investigator: Michael P. Hopkins, MD; MEd         
Sponsors and Collaborators
Aultman Health Foundation
Investigators
Principal Investigator: Laura K Randolph, DO, MS Aultman Health Foundation
  More Information

No publications provided

Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT02028715     History of Changes
Other Study ID Numbers: 2013.08.22.F2
Study First Received: January 2, 2014
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aultman Health Foundation:
IV Acetaminophen
Ofirmev
Post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 26, 2014