Clinical trial

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

Name

UW14030

Description

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.

Trial arms

Trial start

2015-03-17

Estimated PCD

2022-01-03

Trial end

2022-01-03

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Arm I (epidural placement, ERP)

Other names:

Epidural Block, ropivicaine, hydromorphone, Naropin, Dilaudid, Exalgo

Intraoperative Complication Management and Prevention

Undergo ERP

Arms:

Arm I (epidural placement, ERP), Arm II (ERP)

Other names:

Intraoperative Complication Management/Prevention

Pain Therapy

Undergo ERP

Arms:

Arm I (epidural placement, ERP), Arm II (ERP)

Other names:

Analgesia, Pain Control, Pain Management, Pain, Pain Management

Size

104

Primary endpoint

Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)

Up to 24 hours post-surgery

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

Updated at

2023-09-06

1 organization

1 product

3 indications

Organization

University of Wisconsin, Madison

Product

Epidural analgesia

Indication

Intraoperative Complication

Indication

Malignant Neoplasm of Female Reproductive System

Indication

Pain