Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery

PRIMARY OBJECTIVES:

I. Mean postoperative pain score for the first 24 hours post-operatively, (measured by the
Numeric Rating Scale [NRS], which rates pain on a 1-10 scale, collected routinely on the
post-operative floor) will be compared between the epidural and no-epidural groups.

SECONDARY OBJECTIVES:

I. Total opioid use measured in oral morphine equivalents for the first two days
post-surgery.

II. Length of hospital stay (measured in hours from admission to time of discharge order
placement).

III. Post-operative antiemetic use and number of recorded episodes of emesis. IV. Return of
bowel function (measured in hours from completion of surgery to passage of flatus).

V. Subject satisfaction at the 4 week post-operative visit (as measured by two pain
satisfaction questions taken from the Hospital Consumer Assessment of Healthcare Providers
and Systems [HCAHPS] survey).

VI. Post-operative complications (urinary tract infections [UTIs], thromboembolic events,
pneumonia, blood transfusion, myocardial infarction, falls).

VII. Readmission rate. VIII. Epidural discontinuation rates prior to planned removal (in
epidural group only).

IX. Stress and inflammation serum and saliva markers at baseline and the first day after
surgery, as well as at their postoperative visit.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo epidural placement in the First Day Surgery pre-operative area or
similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia
care unit, patients may receive medication via the epidural on an as needed basis, as
determined by the anesthesia team. Dosing and rate of standardized medication will be managed
by the anesthesia team until the epidural is removed. Patients complete the ERP comprising
increased activity, dietary restrictions, fluid balance, as well as anti-nausea,
anti-inflammatory and pain medications at specific times. Patients will have access to
additional pain medications as needed to control their pain.

ARM II: Patients complete the ERP comprising increased activity, dietary restrictions, fluid
balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times.
Patients will have access to additional pain medications as needed to control their pain.

Inclusion Criteria:

- Patients undergoing gynecologic surgery via midline vertical laparotomy at University
of Wisconsin Hospital and Clinics (UWHC)

- Patients must be English speaking

- Patients must have the ability to understand visual and verbal pain scales

- Patients must be eligible for epidural placement

Exclusion Criteria:

- Known allergy to local anesthetics

- Known history of chronic pain disorders and/or chronic opioid use defined as > 10 mg
of oral (PO) morphine or equivalent used daily for at least 30 days prior to
enrollment

- Patient is a prisoner or incarcerated

- Significant liver disease that would inhibit prescription of opioids

- Significant kidney disease that would inhibit administration of gabapentin

- Patient has a history of opioid dependence requiring rehabilitation or the use of
opioid antagonists

- Patient is pregnant

- Patients with a planned exploration with biopsies (no organs removed) will be excluded
from the study