Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02423876
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2015-04-14
Brief Title:
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
UW14030 Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00395 | REGISTRY | None | None |
| 2014-1458 | OTHER | None | None |
| A532820 | OTHER | None | None |
| SMPHOBSTET GYNECGYNEC ONC | OTHER | None | None |
| Protocol Version 11142016 | OTHER | UW Madison | None |