University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
NCT Number: NCT02423876
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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Notify Me18 year and older
Female
Interventional
Phase 3
Madison, Wisconsin, 53792, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive epidural placement. Standard epidural medications and dosage are as follows:
Other names: Epidural Block, ropivicaine, hydromorphone, Naropin, Dilaudid, Exalgo
Undergo ERP
Other names: Intraoperative Complication Management/Prevention
Undergo ERP
Other names: Analgesia, Pain Control, Pain Management, Pain, Pain Management
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.
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.
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.
Time frame: Up to post-operative day 14
Will be tabulated and presented for each group (where applicable).
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.
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.
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.
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.
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.
Time frame: Up to 6 weeks post-surgery
# of events in each group will be reported
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.
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.
University of Wisconsin, Madison
Other
UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery
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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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