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 scoresChange 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
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