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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enhanced Recovery 		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
    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.
    Other names:
    • Toradol
  • Other: Chewing Gum
    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.
    Other names:
    • Xylitol
  • Procedure: Enhanced Recovery Protocol
    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.
Active Comparator
Routine Perioperative Care 		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
    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.
    Other names:
    • Toradol

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.