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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423876
• Other study ID #: UW14030
• Secondary ID: NCI-2015-0039520
• Status: Completed
• Phase: Phase 3
• Start date: March 17, 2015
• Est. completion date: January 3, 2022

Study information

• Verified date: August 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Intraoperative Complication
• Intraoperative Complications
• Malignant Female Reproductive System Neoplasm
• Pain

Intervention

Drug:
• 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.

Other:
• Intraoperative Complication Management and Prevention
Undergo ERP

Procedure:
• Pain Therapy
Undergo ERP

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average Daily Pain Score as Measured by Pain NRS Scores	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.	Up to 2 days following surgery
Secondary	Difference in IL-2 Levels Between Pre-operative and Post-operative Values	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.	Baseline to up to day 1 post-surgery
Secondary	Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)	Will be tabulated and presented for each group (where applicable).	Up to post-operative day 14
Secondary	Length of Hospital Stay (Hours)	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.	From admission to time of discharge order placement
Secondary	Length of Time Until Return of Bowel Function	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.	From completion of surgery to passage of flatus (report in days)
Secondary	Number of Recorded Episodes of Emesis	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.	Up to 5 days post-surgery
Secondary	Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey	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.	At 4 weeks post-operative visit
Secondary	Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After 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.	Up to 4 weeks post-surgery
Secondary	Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)	# of events in each group will be reported	Up to 6 weeks post-surgery
Secondary	Readmission Rate	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.	Up to 6 weeks post-surgery
Secondary	Total Opioid Use Measured in Oral Morphine Equivalents (mg)	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.	Up to first 2 days post-surgery

External Links

•   University of Wisconsin Carbone Cancer Center