Trial Outcomes & Findings for Cesarean Section Via Enhanced Recovery (NCT NCT03552822)
NCT ID: NCT03552822
Last Updated: 2022-08-08
Results Overview
Measurement of opioid consumption in oral morphine equivalents
Recruitment status
COMPLETED
Target enrollment
541 participants
Primary outcome timeframe
From 1 to 72 hours post surgery
Results posted on
2022-08-08
Participant Flow
Participant milestones
| Measure |
ERAS Implemented Group
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
429
|
|
Overall Study
COMPLETED
|
112
|
429
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI was missing for 7 participants (3 in the ERAS Implemented group, 4 in pre-ERAS group)
Baseline characteristics by cohort
| Measure |
ERAS Implemented Group
n=112 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=429 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.79 years
STANDARD_DEVIATION 4.96 • n=112 Participants
|
30.58 years
STANDARD_DEVIATION 5.76 • n=429 Participants
|
30.42 years
STANDARD_DEVIATION 5.61 • n=541 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=112 Participants
|
429 Participants
n=429 Participants
|
541 Participants
n=541 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=112 Participants
|
0 Participants
n=429 Participants
|
0 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=112 Participants
|
10 Participants
n=429 Participants
|
13 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
46 Participants
n=112 Participants
|
181 Participants
n=429 Participants
|
227 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=112 Participants
|
54 Participants
n=429 Participants
|
67 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=112 Participants
|
121 Participants
n=429 Participants
|
159 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=112 Participants
|
40 Participants
n=429 Participants
|
45 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Decline/Unknown/Missing
|
7 Participants
n=112 Participants
|
23 Participants
n=429 Participants
|
30 Participants
n=541 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=112 Participants
|
429 participants
n=429 Participants
|
541 participants
n=541 Participants
|
|
Body Mass Index (BMI)
|
36.73 kg/m^2
STANDARD_DEVIATION 7.84 • n=109 Participants • BMI was missing for 7 participants (3 in the ERAS Implemented group, 4 in pre-ERAS group)
|
35.09 kg/m^2
STANDARD_DEVIATION 14.26 • n=425 Participants • BMI was missing for 7 participants (3 in the ERAS Implemented group, 4 in pre-ERAS group)
|
35.43 kg/m^2
STANDARD_DEVIATION 13.22 • n=534 Participants • BMI was missing for 7 participants (3 in the ERAS Implemented group, 4 in pre-ERAS group)
|
PRIMARY outcome
Timeframe: From 1 to 72 hours post surgeryMeasurement of opioid consumption in oral morphine equivalents
Outcome measures
| Measure |
ERAS Implemented Group
n=112 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=429 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Opioid Consumption
|
60.34 oral morphine equivalents (mg)
Standard Error 4.82
|
104.33 oral morphine equivalents (mg)
Standard Error 4.92
|
SECONDARY outcome
Timeframe: From 1 to 72 hours post surgeryPain scores post-cesarian section will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. Thus, higher values indicate a worse outcome. For each subject, pain scores obtained during the 72 hours post-surgery will be averaged to obtain an overall average pain score.
Outcome measures
| Measure |
ERAS Implemented Group
n=112 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=429 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Overall Average Pain Scores
|
1.61 score on a scale
Standard Error 0.13
|
1.90 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: From 1 to 72 hours post surgeryLength of time between surgery and first recorded ambulation. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Outcome measures
| Measure |
ERAS Implemented Group
n=108 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=424 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Ambulation
|
9.76 hours
Standard Error 0.69
|
32.89 hours
Standard Error 1.23
|
SECONDARY outcome
Timeframe: From 1 to 24 hours post surgeryTime to first oral intake of clear liquids. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Outcome measures
| Measure |
ERAS Implemented Group
n=108 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=424 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Oral Intake
|
2.19 hours
Standard Error 0.07
|
3.58 hours
Standard Error 0.09
|
SECONDARY outcome
Timeframe: From 1 to 72 hours post surgeryTreatment for postoperative nausea and vomiting was assessed using the total amount of ondansetron given postoperatively.
Outcome measures
| Measure |
ERAS Implemented Group
n=112 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=429 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Postoperative Nausea and Vomiting
|
1.82 milligrams (mg)
Standard Error 0.28
|
1.48 milligrams (mg)
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Up to 21 days post surgeryReadmissions to the hospital
Outcome measures
| Measure |
ERAS Implemented Group
n=112 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=429 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Readmission Rates
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From 1 to 24 hours post surgeryTime to Foley catheter removal postoperative. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Outcome measures
| Measure |
ERAS Implemented Group
n=108 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=424 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Foley Catheter Removal
|
11.29 hours
Standard Error 0.71
|
21.17 hours
Standard Error 0.40
|
SECONDARY outcome
Timeframe: 1 hour post surgeryTemperature recorded in post-anesthesia care unit. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Outcome measures
| Measure |
ERAS Implemented Group
n=108 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=424 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Postoperative Temperature
|
97.54 degrees Fahrenheit
Standard Error 0.07
|
97.37 degrees Fahrenheit
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Time of admission until time of discharge, generally not over one weekLength of stay in hospital post-cesarian. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Outcome measures
| Measure |
ERAS Implemented Group
n=108 Participants
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation
|
Pre-ERAS - Non-ERAS Implemented Group
n=424 Participants
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
|
|---|---|---|
|
Hospital Length of Stay
|
81.37 hours
Standard Error 1.85
|
90.76 hours
Standard Error 2.25
|
Adverse Events
ERAS Implemented Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-ERAS - Non-ERAS Implemented Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place