Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay

Study Overview
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Brief Summary
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To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.

Detailed Description
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The investigators hypothesize that an enhanced recovery program which includes several evidence based interventions at the time of cesarean birth in obstetrics will promote early ambulation, resumption of diet and initiation of breastfeeding, and reduce postoperative hospital length of stay. Enhanced Recovery Protocol Components: Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education Minimize preoperative starvation times Moderate amount of clears up to 2 hours prior to anesthesia Solid foods up to 6-8 hours prior to anesthesia Prophylactic antibiotics Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively Chewing gum (Xylitol) to reduce postoperative ileus Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated Early removal of urinary catheter (12 hours postoperatively) Early removal of dressing (6 hours postoperatively) Early mobilization at 12 hours after delivery Early skin-to- skin/breastfeeding initiation Early incentive spirometry Currently, patients are encouraged to ambulate on the first post-operative day, but it is largely left up to the patient when to actually begin to ambulate. They are similarly offered a diet on the first postoperative day but are not encouraged to eat. Breastfeeding is more systematically encouraged early as part of Montefiore's effort to get baby friendly designation. And finally, patients are typically discharged on postoperative day number three unless complications arise in the newborn or the mother. As part of this study, patients in both the enhanced recovery and usual care group will be offered the opportunity to be discharged from the hospital on postoperative day number 2 if their recovery is progressing well and if they choose not to leave then they will be encouraged to return home on postoperative day number 3 according to the current standard of care.

Official Title
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Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: ketorolac
* Other: Chewing Gum
* Procedure: Enhanced Recovery Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation Exclusion Criteria: Women undergoing an urgent or emergent cesarean birth Women less than 18 years old Patients receiving general anesthesia Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta) Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP) Chronic or acute renal impairment Bleeding disorders or platelet dysfunction Peptic ulcer disease or gastrointestinal bleeding Known hypersensitivity to ketorolac (toradol) Active infection at the time of cesarean Cesarean birth prior to 37 weeks Women in significant pain in labor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Recovery<br>Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function. | Drug: ketorolac<br>* Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.<br>* Other names: Toradol;Other: Chewing Gum<br>* Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.<br>* Other names: Xylitol;Procedure: Enhanced Recovery Protocol<br>* enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.<br>|
| Active Comparator: Routine Perioperative Care<br>Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control | Drug: ketorolac<br>* Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge on Postoperative Day #2 | Number of patients discharged on postoperative Day #2 | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Medication Requirement | The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery | 
| Breastfeeding Initiation | All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery | 
| Postoperative Length of Hospital Stay | Postoperative Length of Hospital Stay in Hours from time of surgery | Until patient's day of hospital discharge or a maximum of one month from cesarean delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced Recovery