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

Phase 2

Completed

Conditions: Cesarean Section

Interventions: Drug: ketorolac
Other: Chewing Gum
Procedure: Enhanced Recovery Protocol

Registration Number: NCT02956616

Lead Sponsor: Montefiore Medical Center

Brief Summary: 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: 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:

1. Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education

2. Minimize preoperative starvation times

1. Moderate amount of clears up to 2 hours prior to anesthesia

2. Solid foods up to 6-8 hours prior to anesthesia

3. Prophylactic antibiotics

4. Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively

5. Chewing gum (Xylitol) to reduce postoperative ileus

6. Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use

7. Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated

8. Early removal of urinary catheter (12 hours postoperatively)

9. Early removal of dressing (6 hours postoperatively)

10. Early mobilization at 12 hours after delivery

11. Early skin-to- skin/breastfeeding initiation

12. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 118

Inclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Recovery	Chewing Gum	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.
Enhanced Recovery	Enhanced Recovery Protocol	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.
Enhanced Recovery	ketorolac	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.
Routine Perioperative Care	ketorolac	Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control

Primary Outcome Measures

Name	Time	Method
Discharge on Postoperative Day #2	Until patient's day of hospital discharge or a maximum of one month from cesarean delivery	Number of patients discharged on postoperative Day #2

Secondary Outcome Measures

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