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

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain

Intervention: Epidural analgesia (Drug); Intraoperative Complication Management and Prevention (Other); Pain Therapy (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Lisa Barroilhet, Principal Investigator, Affiliation: University of Wisconsin Hospital and Clinics

Overall contact:
Cancer Connect, Phone: (800) 622-8922, Email: cancerconnect@uwcarbone.wisc.edu

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.

Clinical Details

Official title: UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Relative pain scores, as measured by the Pain NRS

Secondary outcome:

Average daily pain score as measured by Pain NRS scores

Change in stress and inflammation serum markers as measured by interleukin (IL)-2, IL-6, tumor necrosis factor, C-reactive protein, and salivary cortisol levels

Epidural discontinuation rates prior to planned removal (in epidural group only)

Length of hospital stay

Length of time until return of bowel function

Number of recorded episodes of emesis

Patient satisfaction scores, as measured by the HCAHPS, NRS, and Brief Pain Inventory

Post-operative antiemetic use

Post-operative complications (UTIs, thromboembolic events, pneumonia, blood transfusion, myocardial infarction, falls)

Readmission rate

Total opioid use measured in oral morphine equivalents

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Cancer Connect, Phone: (800) 622-8922, Email: cancerconnect@uwcarbone.wisc.edu

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin 53792, United States; Recruiting
Cancer M. Connect, Phone: 800-622-8922, Email: cancerconnect@uwcarbone.wisc.edu
Lisa M. Barroilhet, Principal Investigator
Additional Information

Starting date: March 2015
Last updated: April 28, 2015

Page last updated: August 23, 2015

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