Post-operative Pain | Efficacy of IV Acetaminophen for Pain Management
Post-operative Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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.
Drug:IV acetaminophenIV 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ControlMorphine 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 (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.
Start Date: January 2014
Completed Date: July 2016
Phase: Phase 4
Primary Outcome: Amount of opioid rescue needed
Secondary Outcome: Time to return of bowel function (passage of flatus)
Study sponsors, principal investigator, and references
Principal Investigator: Laura K Randolph, DO, MS
Lead Sponsor: Aultman Health Foundation