Intraoperative ComplicationPhase 3NCT02423876
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
A Phase 3 study testing Epidural analgesia, Intraoperative Complication Management and Prevention and Pain Therapy in people with Intraoperative Complication and Malignant Female Reproductive System Neoplasm, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intraoperative Complication, Malignant Female Reproductive System Neoplasm, Pain
- What is being tested?
- Epidural analgesia, Intraoperative Complication Management and Prevention and Pain Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2015to 3 Jan 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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.
- Being tested
- Epidural analgesia, Intraoperative Complication Management and Prevention, Pain Therapy
- Medical subject headings
- Intraoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaDrug
Also called Epidural Block, ropivicaine, hydromorphone, Naropin
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.
Intraoperative Complication Management and PreventionOther
Also called Intraoperative Complication Management/Prevention
Undergo ERP
Pain TherapyProcedure or surgery
Also called Analgesia, Pain Control, Pain Management, Pain, Pain Management
Undergo ERP
| Study group | Role | What they receive |
|---|---|---|
| Arm I (epidural placement, ERP) | Experimental | 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. Receives: Drug: Epidural analgesia; Other: Intraoperative Complication Management and Prevention; Procedure: Pain Therapy |
| Arm II (ERP) | Active comparator | 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. Receives: Other: Intraoperative Complication Management and Prevention; Procedure: Pain Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours post-surgery
Secondary outcomes (11)
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.
Measured: Up to 2 days following surgery
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.
Measured: Baseline to up to day 1 post-surgery
Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)
Will be tabulated and presented for each group (where applicable).
Measured: Up to post-operative day 14
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.
Measured: From admission to time of discharge order placement
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.
Measured: From completion of surgery to passage of flatus (report in days)
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.
Measured: 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
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.
Measured: At 4 weeks post-operative visit
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.
Measured: Up to 4 weeks post-surgery
Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)
# of events in each group will be reported
Measured: Up to 6 weeks post-surgery
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.
Measured: Up to 6 weeks post-surgery
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.
Measured: Up to first 2 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start17 Mar 2015
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraoperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Barroilhet, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423876
- Sponsor's protocol ID
- UW14030
- Other IDs
- NCI-2015-00395, 2014-1458, A532820, SMPH\OBSTET & GYNEC\GYNEC ONC, Protocol Version 11/14/2016
- Status last verified
- Aug 2023
- First submitted
- 14 Apr 2015
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes