- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02423876
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (epidural placement, ERP)
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.
|
Receive epidural placement. Standard epidural medications and dosage are as follows:
Other Names:
Undergo ERP
Other Names:
Undergo ERP
Other Names:
|
Active Comparator: Arm II (ERP)
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.
|
Undergo ERP
Other Names:
Undergo ERP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 24 hours post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 days following surgery
|
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.
|
Baseline to up to day 1 post-surgery
|
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).
|
Up to post-operative day 14
|
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.
|
From admission to time of discharge order placement
|
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.
|
From completion of surgery to passage of flatus (report in days)
|
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.
|
Up to 5 days post-surgery
|
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.
|
At 4 weeks post-operative visit
|
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.
|
Up to 4 weeks post-surgery
|
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
|
Up to 6 weeks post-surgery
|
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.
|
Up to 6 weeks post-surgery
|
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.
|
Up to first 2 days post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Barroilhet, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Intraoperative Complications
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Hydromorphone
Other Study ID Numbers
- UW14030
- NCI-2015-00395 (Registry Identifier: NCI Trial ID)
- 2014-1458 (Other Identifier: HS-IRB)
- A532820 (Other Identifier: UW Madison)
- SMPH\OBSTET & GYNEC\GYNEC ONC (Other Identifier: UW Madison)
- Protocol Version 11/14/2016 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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