Efficacy of IV Acetaminophen for Pain Management

NCT ID: NCT02028715

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-24
• Study Completion Date: 2014-06-04

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:

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

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental (Normal Saline)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

IV acetaminophen

Intervention Type: DRUG

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.

Interventions

Placebo

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

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.

Intervention Type: DRUG

Other Intervention Names

IV Placebo; Ofirmev

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aultman Health Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura K Randolph, DO, MS

Role: PRINCIPAL_INVESTIGATOR

Aultman Health Foundation

Locations

Aultman Health Foundation

Canton, Ohio, United States

Countries

United States

Other Identifiers

2013.08.22.F2

Identifier Type: -

Identifier Source: org_study_id