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Completed

NCT Number: NCT02423876

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Epidural Block, ropivicaine, hydromorphone, Naropin, Dilaudid, Exalgo

Intraoperative Complication Management and Prevention

Other

Undergo ERP

Other names: Intraoperative Complication Management/Prevention

pain therapy

Procedure

Undergo ERP

Other names: Analgesia, Pain Control, Pain Management, Pain, Pain Management

Primary outcomes

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

    Time frame: Up to 24 hours post-surgery

    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.

Secondary outcomes

  1. Average Daily Pain Score as Measured by Pain NRS Scores

    Time frame: Up to 2 days following surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

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

    Time frame: Baseline to up to day 1 post-surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

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

    Time frame: Up to post-operative day 14

    Will be tabulated and presented for each group (where applicable).

  4. Length of Hospital Stay (Hours)

    Time frame: From admission to time of discharge order placement

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

  5. Length of Time Until Return of Bowel Function

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

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

  6. Number of Recorded Episodes of Emesis

    Time frame: Up to 5 days post-surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

  7. Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey

    Time frame: At 4 weeks post-operative visit

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Scores range from 1 to 4, with higher scores indicating higher satisfaction.

  8. Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)

    Time frame: Up to 4 weeks post-surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

  9. Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)

    Time frame: Up to 6 weeks post-surgery

    # of events in each group will be reported

  10. Readmission Rate

    Time frame: Up to 6 weeks post-surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

  11. Total Opioid Use Measured in Oral Morphine Equivalents (mg)

    Time frame: Up to first 2 days post-surgery

    Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2015
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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