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

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ClinicalTrials.gov Identifier: NCT02956616
Recruitment Status : Completed
First Posted : November 7, 2016
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Peter S. Bernstein, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: ketorolac Other: Chewing Gum Procedure: Enhanced Recovery Protocol Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Ketorolac

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Toradol




Primary Outcome Measures :
  1. Discharge on Postoperative Day #2 [ Time Frame: 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 :
  1. Postoperative Pain Medication Requirement [ Time Frame: 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

  2. Breastfeeding Initiation [ Time Frame: 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

  3. Postoperative Length of Hospital Stay [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956616


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Peter S. Bernstein, Montefiore Medical Center:

Publications of Results:
Other Publications:

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Responsible Party: Peter S. Bernstein, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02956616     History of Changes
Other Study ID Numbers: 2016-6966
First Posted: November 7, 2016    Key Record Dates
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter S. Bernstein, Montefiore Medical Center:
Enhanced Recovery
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action