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Efficacy of IV Acetaminophen for Pain Management

Primary Purpose

Post-operative Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebo

IV acetaminophen

About this trial

This is an interventional supportive care trial for Post-operative Pain focused on measuring IV Acetaminophen, Ofirmev, Post-operative pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Aultman Health Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Experimental (Normal Saline)

Experimental (IV Acetaminophen)

Arm Description

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.

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

Primary Outcome Measures

Opioid Rescue - 48 Hours

Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine

Secondary Outcome Measures

Return of Bowel Function

Time to return of bowel function (passage of flatus) in hours

Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Length of Stay

Mean length of post-operative stay in days

Full Information

NCT ID

NCT02028715

First Posted

January 2, 2014

Last Updated

January 2, 2019

Sponsor

Aultman Health Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02028715

Brief Title

Efficacy of IV Acetaminophen for Pain Management

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 24, 2013 (Actual)

Primary Completion Date

June 4, 2014 (Actual)

Study Completion Date

June 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aultman Health Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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, 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 effective postoperative pain management approach.

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: 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. 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; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain

Keywords

IV Acetaminophen, Ofirmev, Post-operative pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental (Normal Saline)

Arm Type

Placebo Comparator

Arm Description

Arm Title

Experimental (IV Acetaminophen)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

IV Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

IV acetaminophen

Other Intervention Name(s)

Ofirmev

Intervention Description

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.

Primary Outcome Measure Information:

Title

Opioid Rescue - 48 Hours

Description

Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine

Time Frame

First 48 hours including pre-operative and intra-operative medications

Secondary Outcome Measure Information:

Title

Return of Bowel Function

Description

Time to return of bowel function (passage of flatus) in hours

Time Frame

Duration of hospital stay (up to 7 days).

Title

Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge

Description

Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Time Frame

At 24 hours 48 hours, and discharge (up to 7 days)

Title

Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge

Description

Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Time Frame

At 24 hours, 48 Hours, and Discharge (up to 7 days)

Title

Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge

Description

Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Time Frame

At 24 hours, 48 Hours, and Discharge (up to 7 days)

Title

Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge

Description

Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree

Time Frame

At 24 hours, 48 Hours, and Discharge (up to 7 days)

Title

Length of Stay

Description

Mean length of post-operative stay in days

Time Frame

Surgery to discharge

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura K Randolph, DO, MS

Organizational Affiliation

Aultman Health Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aultman Health Foundation

City

Canton

State/Province

Ohio

ZIP/Postal Code

44720

Country

United States

12. IPD Sharing Statement

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Efficacy of IV Acetaminophen for Pain Management

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