IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy



Status:Completed
Conditions:Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 75
Updated:6/15/2018
Start Date:February 2015
End Date:September 2016

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Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial

The objective of this study is to quantify the change in post-operative pain scores and
narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to
placebo in women undergoing laparoscopic hysterectomy.

Gynecologic surgery has been revolutionized by the incorporation of minimally invasive
techniques. Procedures that once resulted in multiple day hospital admissions are now being
performed in outpatient surgery centers. Common factors that contribute to delayed discharge
are inadequate postoperative pain control and increased nausea and vomiting. A multi-modal
pain management approach is considered optimal at controlling postsurgical pain, which
includes combining different analgesics that act in varying mechanisms. By using medications
that act synergistically, the overall analgesia requirement can oftentimes be decreased.

Opioids have been found to be highly effective in controlling postoperative pain; however,
are associated with dose-dependent risks including nausea, vomiting, constipation, urinary
retention, sedation, and respiratory depression. Subsequently, non-opioid options are
frequently desired in an attempt to minimize narcotic intake. In the United States,
intravenous acetaminophen was approved by the US Food and Drug Administration (FDA) in
November 2010 for the management of mild to moderate pain and the reduction of fever. Since
this time, multiple studies have analyzed the role of intravenous acetaminophen in both acute
and postoperative pain; however, none have been specific to laparoscopic hysterectomy. The
primary study published evaluating intravenous acetaminophen in laparoscopic hysterectomies
also included multiple other laparoscopic procedures from a variety of specialties including
general surgery, urology, and urogynecology. In addition, the intravenous acetaminophen was
started on average 19 hours after the conclusion of the case once the patient controlled
analgesic was discontinued.

Improved postsurgical pain control achieved with intravenous acetaminophen may potentially
lead to same day discharge after major laparoscopic gynecologic procedures. Same day
discharge after laparoscopic hysterectomy has been shown to be a safe option with proper
patient counseling and multi-modal pain medications. In addition, same day discharge is also
associated with decreased health care expenditures. With continued efforts to cut hospital
costs, the pressure to discharge patients earlier continues to be high.

The investigators propose that intravenous acetaminophen will improve post-operative pain
control and decrease narcotic requirements for patients undergoing laparoscopic
hysterectomies. Furthermore, The investigators expect to find decreased postsurgical nausea
and vomiting and potentially quicker discharge to home. This could have a large impact on the
field of gynecologic surgery as major procedures that once required overnight admission may
now succeed at same day discharge.

Inclusion Criteria:

- Women aged 18-75

- Ability to read and write in English (our post-operative pain log is only available in
English)

- Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy,
laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal
hysterectomy, with or without salpingooophorectomy)

Exclusion Criteria:

- Answering yes to any of the following questions: "Do you have a history of liver
disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks
per day or being have you ever been told by your doctor that they should not take
acetaminophen"

- History of cardiac arrhythmia

- History of jaundice

- Acute abdominal inflammatory or infectious process at time of surgery

- Known malignancy at time of surgery

- Known pregnancy at time of surgery

- Plan to perform additional significant surgical procedure at the time of hysterectomy
such as extensive excision of endometriosis on bowel or bladder or pelvic
reconstructive procedure

- >6cm abdominal incision in order to remove the uterus at time of study-related
hysterectomy

- Regular use of narcotic pain medication (defined as use on most days of the week at
any point in the past 3 months)

- Allergy to acetaminophen

- Women who weigh less than 50 kilograms on the day of surgery.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Phone: 412-641-4163
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mi
from
Pittsburgh, PA
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