Clinical trial NCT02423876: Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
Official title: UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intraoperative Complication
Malignant Female Reproductive System Neoplasm
Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays in place for several days after surgery and may be helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of specific steps used before, during, and after surgery by health care providers to care for patients after surgery. ERPs include patient education, not using laxatives before surgery, increasing activity after surgery, and scheduled use of medications for pain and nausea. Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing gynecologic surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)
timeFrame: Up to 24 hours post-surgery
Secondary outcomes:
measure: Average Daily Pain Score as Measured by Pain NRS Scores
timeFrame: Up to 2 days following surgery
measure: Difference in IL-2 Levels Between Pre-operative and Post-operative Values
timeFrame: Baseline to up to day 1 post-surgery
measure: Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)
timeFrame: Up to post-operative day 14
measure: Length of Hospital Stay (Hours)
timeFrame: From admission to time of discharge order placement
measure: Length of Time Until Return of Bowel Function
timeFrame: From completion of surgery to passage of flatus (report in days)
measure: Number of Recorded Episodes of Emesis
timeFrame: Up to 5 days post-surgery
measure: Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
timeFrame: At 4 weeks post-operative visit
measure: Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)
timeFrame: Up to 4 weeks post-surgery
measure: Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)
timeFrame: Up to 6 weeks post-surgery
measure: Readmission Rate
timeFrame: Up to 6 weeks post-surgery
measure: Total Opioid Use Measured in Oral Morphine Equivalents (mg)
timeFrame: Up to first 2 days post-surgery
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Barroilhet
role: PRINCIPAL_INVESTIGATOR
References: