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

NCT02423876 | Completed Phase 3 Results DMC

• 6 other identifiers: UW14030NCI-2015-003952014-1458A532820SMPH\OBSTET & GYNEC\GYNEC ONCProtocol Version 11/14/2016
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain

Outcome Measures

Primary Outcomes (1)

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

  Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable.

  Up to 24 hours post-surgery

Secondary Outcomes (11)

• Average Daily Pain Score as Measured by Pain NRS Scores

  Up to 2 days following surgery

• Difference in IL-2 Levels Between Pre-operative and Post-operative Values

  Baseline to up to day 1 post-surgery

• Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)

  Up to post-operative day 14

• Length of Hospital Stay (Hours)

  From admission to time of discharge order placement

• Length of Time Until Return of Bowel Function

  From completion of surgery to passage of flatus (report in days)

Study Arms (2)

Arm I (epidural placement, ERP)

EXPERIMENTAL

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.

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

Arm II (ERP)

ACTIVE COMPARATOR

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.

Other: Intraoperative Complication Management and Prevention; Procedure: Pain Therapy

Interventions

Epidural analgesia 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.

Also known as: Epidural Block, ropivicaine, hydromorphone, Naropin, Dilaudid, Exalgo

Arm I (epidural placement, ERP)

Intraoperative Complication Management and Prevention OTHER

Undergo ERP

Also known as: Intraoperative Complication Management/Prevention

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

Pain Therapy PROCEDURE

Undergo ERP

Also known as: Analgesia, Pain Control, Pain Management, Pain, Pain Management

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Intraoperative Complications; Pain

Interventions

Analgesia, Epidural; Anesthesia, Epidural; Hydromorphone; Ropivacaine; Analgesia; Pain Management

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Limitations and Caveats

Cytokine samples were not able to be interpreted due to huge variances, and they are being run again on a different flow cytometry machine.

Results Point of Contact

• Title: Cancer Connect
• Organization: University of Wisconsin Carbone Cancer Center

clinicaltrials@cancer.wisc.edu

800-622-8922

Study Officials

• Lisa Barroilhet

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 22, 2015
• Study Start: March 17, 2015
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2023-08

Locations

US (1)