Phase 3 N=104 Randomized Supportive Care

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

Intraoperative Complication · Malignant Female Reproductive System Neoplasm · Pain

Bottom Line

View on ClinicalTrials.gov: NCT02423876 ↗

Enrolled (actual)

104

Serious AEs

1.9%

Results posted

Sep 2023

Primary outcome: Primary: Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS) — 3.87; 4.95 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Epidural analgesia (Drug); Intraoperative Complication Management and Prevention (Other); Pain Therapy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Wisconsin, Madison
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)	3.87; 4.95	—
SECONDARY Average Daily Pain Score as Measured by Pain NRS Scores	3.98; 5.12	—
SECONDARY Difference in IL-2 Levels Between Pre-operative and Post-operative Values	9.6; 15.5	—
SECONDARY Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)	4	—
SECONDARY Length of Hospital Stay (Hours)	99.83; 87.25	—
SECONDARY Length of Time Until Return of Bowel Function	2.22; 2.20	—
SECONDARY Number of Recorded Episodes of Emesis	.192; .1875	—
SECONDARY Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey	3.78; 3.87	—
SECONDARY Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)	4.46; 3.17	—
SECONDARY Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)	15; 12	—
SECONDARY Readmission Rate	2; 2	—
SECONDARY Total Opioid Use Measured in Oral Morphine Equivalents (mg)	50.1; 82.56	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02423876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.