Cesarean Section
Conditions
Brief summary
Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of stay (LOS). At the University of Alabama at Birmingham (UAB), the institution has had successful implementation of ERAS protocols for several surgical specialties including colorectal, breast, spine, gynecology, and gynecology-oncology. However, the institution currently does not have a protocol in place for the most commonly performed surgical procedure - cesarean delivery. At UAB, the institution performs approximately 1,000 cesarean deliveries per year. The investigators believe that an ERAS protocol will be beneficial for these patients. Currently, there is very little data published on ERAS protocols. Although this patient population is ideal for an ERAS protocol, there are several barriers that have to be overcome. The data published show promising results for ERAS protocols with cesarean delivery. A larger tertiary care center showed earlier discharge with lower re-admission rates with an ERAS pathway. Currently, the investigators have created a multidisciplinary group at UAB to establish an ERAS protocol for patients undergoing cesarean delivery. This group includes anesthesiologists, obstetricians, nursing, neonatology, pharmacy, and informatics. Once the investigators have implemented this protocol, the investigators would like to perform a retrospective analysis to determine if there are any significant changes in our desired outcomes the investigators will study. Our goal is to demonstrate significantly improved outcomes in the investigators' measured endpoints. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for cesarean deliveries, there currently is very little published on the subject. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
Detailed description
The investigators are implementing an enhanced recovery after surgery (ERAS) protocol for patients undergoing cesarean delivery. The purpose of the ERAS protocol is to optimize care provided to patients (patient education, nutrition, pain management, early ambulation, etc.). The anticipated date of protocol initiation is May 2018. Once this protocol has been in place for approximately 6 months to one year, the investigators would like to retrospectively review data on these patients and compare outcomes to a similarly-matched group of patients the year preceding protocol implementation. Specific outcomes the investigators will assess are: hospital length of stay, post-operative pain scores, opioid consumption, patient satisfaction \[through IRB-approved survey (protocol X300001121)\], surgical site infection rates, readmission rates, and unscheduled clinic and maternal evaluation unit (MEU) visits before the first scheduled postpartum visit. The investigators also plan to track compliance monthly with the adherence to the protocol. Since the investigators want to track compliance (both as a quality improvement project as well as research), the investigators are requesting (Institutional Review Board) IRB approval now.
Interventions
OTHERERAS Protocol Implementation
Implementation of ERAS Protocol Implementation
Sponsors
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Any patient 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, Maternal Fetal Medicine (MFM), Obstetrics Complications Clinic (OBCC).
Exclusion criteria
1. Age less than 18 years old; 2. urgent or emergent cesarean delivery; 3. diagnosis of preeclampsia; 4. coagulopathy that contraindicates neuraxial block placement; 5. abnormal placentation; 6. opioid abuse disorder; 7. type C diabetic or greater.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | From 1 to 72 hours post surgery | Measurement of opioid consumption in oral morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation | From 1 to 72 hours post surgery | Length 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. |
| Oral Intake | From 1 to 24 hours post surgery | Time 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. |
| Postoperative Nausea and Vomiting | From 1 to 72 hours post surgery | Treatment for postoperative nausea and vomiting was assessed using the total amount of ondansetron given postoperatively. |
| Overall Average Pain Scores | From 1 to 72 hours post surgery | Pain 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. |
| Foley Catheter Removal | From 1 to 24 hours post surgery | Time 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. |
| Postoperative Temperature | 1 hour post surgery | Temperature 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. |
| Hospital Length of Stay | Time of admission until time of discharge, generally not over one week | Length 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. |
| Readmission Rates | Up to 21 days post surgery | Readmissions to the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ERAS Implemented Group Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
ERAS Protocol Implementation: Implementation of ERAS Protocol Implementation | 112 |
| Pre-ERAS - Non-ERAS Implemented Group Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery. | 429 |
| Total | 541 |
Baseline characteristics
| Characteristic | ERAS Implemented Group | Pre-ERAS - Non-ERAS Implemented Group | Total |
|---|---|---|---|
| Age, Continuous | 29.79 years STANDARD_DEVIATION 4.96 | 30.58 years STANDARD_DEVIATION 5.76 | 30.42 years STANDARD_DEVIATION 5.61 |
| Body Mass Index (BMI) | 36.73 kg/m^2 STANDARD_DEVIATION 7.84 | 35.09 kg/m^2 STANDARD_DEVIATION 14.26 | 35.43 kg/m^2 STANDARD_DEVIATION 13.22 |
| Race/Ethnicity, Customized Asian | 3 Participants | 10 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 46 Participants | 181 Participants | 227 Participants |
| Race/Ethnicity, Customized Decline/Unknown/Missing | 7 Participants | 23 Participants | 30 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 13 Participants | 54 Participants | 67 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 40 Participants | 45 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 121 Participants | 159 Participants |
| Region of Enrollment United States | 112 participants | 429 participants | 541 participants |
| Sex: Female, Male Female | 112 Participants | 429 Participants | 541 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 429 |
| other Total, other adverse events | 0 / 112 | 0 / 429 |
| serious Total, serious adverse events | 0 / 112 | 0 / 429 |
Outcome results
Primary
Opioid Consumption
Measurement of opioid consumption in oral morphine equivalents
Time frame: From 1 to 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Opioid Consumption | 60.34 oral morphine equivalents (mg) | Standard Error 4.82 |
| Pre-ERAS - Non-ERAS Implemented Group | Opioid Consumption | 104.33 oral morphine equivalents (mg) | Standard Error 4.92 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Ambulation
Length 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.
Time frame: From 1 to 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Ambulation | 9.76 hours | Standard Error 0.69 |
| Pre-ERAS - Non-ERAS Implemented Group | Ambulation | 32.89 hours | Standard Error 1.23 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Foley Catheter Removal
Time 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.
Time frame: From 1 to 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Foley Catheter Removal | 11.29 hours | Standard Error 0.71 |
| Pre-ERAS - Non-ERAS Implemented Group | Foley Catheter Removal | 21.17 hours | Standard Error 0.4 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Hospital Length of Stay
Length 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.
Time frame: Time of admission until time of discharge, generally not over one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Hospital Length of Stay | 81.37 hours | Standard Error 1.85 |
| Pre-ERAS - Non-ERAS Implemented Group | Hospital Length of Stay | 90.76 hours | Standard Error 2.25 |
p-value: 0.085Wilcoxon (Mann-Whitney)
Secondary
Oral Intake
Time 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.
Time frame: From 1 to 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Oral Intake | 2.19 hours | Standard Error 0.07 |
| Pre-ERAS - Non-ERAS Implemented Group | Oral Intake | 3.58 hours | Standard Error 0.09 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Overall Average Pain Scores
Pain 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.
Time frame: From 1 to 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Overall Average Pain Scores | 1.61 score on a scale | Standard Error 0.13 |
| Pre-ERAS - Non-ERAS Implemented Group | Overall Average Pain Scores | 1.90 score on a scale | Standard Error 0.07 |
p-value: 0.037Wilcoxon (Mann-Whitney)
Secondary
Postoperative Nausea and Vomiting
Treatment for postoperative nausea and vomiting was assessed using the total amount of ondansetron given postoperatively.
Time frame: From 1 to 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Postoperative Nausea and Vomiting | 1.82 milligrams (mg) | Standard Error 0.28 |
| Pre-ERAS - Non-ERAS Implemented Group | Postoperative Nausea and Vomiting | 1.48 milligrams (mg) | Standard Error 0.14 |
p-value: 0.108Wilcoxon (Mann-Whitney)
Secondary
Postoperative Temperature
Temperature 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.
Time frame: 1 hour post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERAS Implemented Group | Postoperative Temperature | 97.54 degrees Fahrenheit | Standard Error 0.07 |
| Pre-ERAS - Non-ERAS Implemented Group | Postoperative Temperature | 97.37 degrees Fahrenheit | Standard Error 0.02 |
p-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
Readmission Rates
Readmissions to the hospital
Time frame: Up to 21 days post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ERAS Implemented Group | Readmission Rates | 3 Participants |
| Pre-ERAS - Non-ERAS Implemented Group | Readmission Rates | 4 Participants |
p-value: 0.159Fisher Exact