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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Cesarean Section

Treatments: Procedure: Enhanced Recovery Protocol; Drug: ketorolac; Other: Chewing Gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02956616

2016-6966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

Exclusion criteria

1. Women undergoing an urgent or emergent cesarean birth
2. Women less than 18 years old
3. Patients receiving general anesthesia
4. Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
5. Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
6. Chronic or acute renal impairment
7. Bleeding disorders or platelet dysfunction
8. Peptic ulcer disease or gastrointestinal bleeding
9. Known hypersensitivity to ketorolac (toradol)
10. Active infection at the time of cesarean
11. Cesarean birth prior to 37 weeks
12. Women in significant pain in labor

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Enhanced Recovery

Experimental group

Description:

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.

Treatment:

Other: Chewing Gum

Procedure: Enhanced Recovery Protocol

Drug: ketorolac

Routine Perioperative Care

Active Comparator group

Description:

Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control

Treatment:

Drug: ketorolac