Trial Outcomes & Findings for Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery (NCT NCT02423876)

Last Updated: 2023-09-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

104 participants

Primary outcome timeframe

Up to 24 hours post-surgery

Results posted on

2023-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Overall Study STARTED	52	52
Overall Study COMPLETED	52	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=52 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP	Total n=104 Participants Total of all reporting groups
Age, Customized 20-29 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 30-39 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 40-49 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Customized 50-59 years	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized 60-69 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Customized 70-79 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 80-89 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	52 participants n=7 Participants	104 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours post-surgery

Population: Modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)	3.87 score on a scale Interval 3.35 to 4.38	4.95 score on a scale Interval 4.25 to 5.65

SECONDARY outcome

Timeframe: Up to 2 days following surgery

Population: modified intent to treat

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.

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Average Daily Pain Score as Measured by Pain NRS Scores	3.98 score on a scale Interval 3.27 to 4.42	5.12 score on a scale Interval 4.33 to 5.61

SECONDARY outcome

Timeframe: Baseline to up to day 1 post-surgery

Population: Modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=41 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=42 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Difference in IL-2 Levels Between Pre-operative and Post-operative Values	9.6 nmol/L Interval 8.1 to 10.4	15.5 nmol/L Interval 14.0 to 16.3

SECONDARY outcome

Timeframe: Up to post-operative day 14

Will be tabulated and presented for each group (where applicable).

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=48 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)	4 Participants	—

SECONDARY outcome

Timeframe: From admission to time of discharge order placement

Population: Modified intent to treat

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=45 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Length of Hospital Stay (Hours)	99.83 hours Interval 79.22 to 120.43	87.25 hours Interval 73.45 to 101.05

SECONDARY outcome

Timeframe: From completion of surgery to passage of flatus (report in days)

Population: modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=51 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=46 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Length of Time Until Return of Bowel Function	2.22 days Interval 1.91 to 2.52	2.20 days Interval 1.95 to 2.44

SECONDARY outcome

Timeframe: Up to 5 days post-surgery

Population: modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Number of Recorded Episodes of Emesis	.192 number of episodes Interval 0.046 to 0.339	.1875 number of episodes Interval 0.045 to 0.33

SECONDARY outcome

Timeframe: At 4 weeks post-operative visit

Population: Modified intent to treat

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=46 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=39 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey	3.78 score on a scale of 1-4 Interval 3.65 to 3.9	3.87 score on a scale of 1-4 Interval 3.76 to 3.98

SECONDARY outcome

Timeframe: Up to 4 weeks post-surgery

Population: modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)	4.46 mg Interval 3.02 to 5.9	3.17 mg Interval 2.04 to 4.29

SECONDARY outcome

Timeframe: Up to 6 weeks post-surgery

Population: modified intent to treat

\# of events in each group will be reported

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)	15 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks post-surgery

Population: modified intent to treat

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Readmission Rate	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to first 2 days post-surgery

Population: Modified intent to treat analysis

Outcome measures

Outcome measures
Measure	Arm I (Epidural Placement, ERP) n=52 Participants 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=48 Participants 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Total Opioid Use Measured in Oral Morphine Equivalents (mg)	50.1 mg Interval 34.48 to 65.72	82.56 mg Interval 63.13 to 101.97

Adverse Events

Arm I (Epidural Placement, ERP)

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Arm II (ERP)

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Epidural Placement, ERP) n=52 participants at risk 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=52 participants at risk 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Infections and infestations wound infection, fascial dehiscence	1.9% 1/52 • Number of events 1 • Up to 6 weeks	0.00% 0/52 • Up to 6 weeks
Infections and infestations pneumonia	0.00% 0/52 • Up to 6 weeks	1.9% 1/52 • Number of events 1 • Up to 6 weeks

Other adverse events

Other adverse events
Measure	Arm I (Epidural Placement, ERP) n=52 participants at risk 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. Epidural analgesia: 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 Prevention: Undergo ERP Pain Therapy: Undergo ERP	Arm II (ERP) n=52 participants at risk 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. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP
Blood and lymphatic system disorders anemia	67.3% 35/52 • Number of events 35 • Up to 6 weeks	53.8% 28/52 • Number of events 28 • Up to 6 weeks
Blood and lymphatic system disorders vascular thrombolic event	3.8% 2/52 • Number of events 2 • Up to 6 weeks	5.8% 3/52 • Number of events 3 • Up to 6 weeks

Additional Information

Cancer Connect

University of Wisconsin Carbone Cancer Center

Phone: 800-622-8922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place