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

NCT ID: NCT02423876

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-17
• Study Completion Date: 2022-01-03

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.

Conditions

Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (epidural placement, ERP)

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.

Group Type: EXPERIMENTAL

Epidural analgesia

Intervention Type: DRUG

Receive epidural placement. Standard epidural medications and dosage are as follows:

• 0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate
• 3 mL/hr RN bolus, to be used as needed based on pain ratings
• 3 mL/30 minutes patient bolus, which is available on patient demand.

Intraoperative Complication Management and Prevention

Intervention Type: OTHER

Undergo ERP

Pain Therapy

Intervention Type: PROCEDURE

Undergo ERP

Arm II (ERP)

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.

Group Type: ACTIVE_COMPARATOR

Intraoperative Complication Management and Prevention

Intervention Type: OTHER

Undergo ERP

Pain Therapy

Intervention Type: PROCEDURE

Undergo ERP

Interventions

Epidural analgesia

Receive epidural placement. Standard epidural medications and dosage are as follows:

• 0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate
• 3 mL/hr RN bolus, to be used as needed based on pain ratings
• 3 mL/30 minutes patient bolus, which is available on patient demand.

Intervention Type: DRUG

Intraoperative Complication Management and Prevention

Undergo ERP

Intervention Type: OTHER

Pain Therapy

Undergo ERP

Intervention Type: PROCEDURE

Other Intervention Names

Epidural Block; ropivicaine; hydromorphone; Naropin; Dilaudid; Exalgo; Intraoperative Complication Management/Prevention; Analgesia; Pain Control; Pain Management; Pain, Pain Management

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Barroilhet

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

NCI-2015-00395

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-1458

Identifier Type: OTHER

Identifier Source: secondary_id

A532820

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\OBSTET & GYNEC\GYNEC ONC

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 11/14/2016

Identifier Type: OTHER

Identifier Source: secondary_id

UW14030

Identifier Type: -

Identifier Source: org_study_id