Efficacy of IV Acetaminophen for Pain Management
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/18/2019 |
| Start Date: | December 24, 2013 |
| End Date: | June 4, 2014 |
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.
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.
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.
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.
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.
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.
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