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Trial record 4 of 5 for:    26977696 [PUBMED-IDS]

Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section

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ClinicalTrials.gov Identifier: NCT03330119
Recruitment Status : Terminated (Lack of Funding/ Resident in charge graduated)
First Posted : November 6, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Norman A. Brest, Brest, Norman A., M.D.

Brief Summary:

This randomized controlled trial will compare two different approaches to patient recovery after cesarean section: the current standard of care versus an alternate management protocol. The goal of this study is to investigate whether an "alternate management" protocol after cesarean sections will yield the same results as alternate management in other surgical fields, including decreased narcotic consumption and quicker return of bowel function, without compromising patient morbidity or satisfaction.

The investigators will assess postoperative narcotic consumption as the primary outcome. Secondary outcomes will be return of bowel function, length of hospital stay, pain control, patient satisfaction, post-operative complications, and overall morbidity and mortality.

Hypothesis: Initiating the alternate management protocol for cesarean sections will decrease narcotic consumption and hasten return of bowel function, without compromising patient satisfaction, level of pain control, or post-operative morbidity.


Condition or disease Intervention/treatment Phase
Pregnancy Related Narcotic Use Drug: Alternate Management Drug: Control Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section
Actual Study Start Date : October 4, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Alternate Management Drug: Alternate Management
With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
Other Name: Enhanced Recovery

Placebo Comparator: Control
The regular Lankenau cesarean section order set.
Drug: Control
The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request.




Primary Outcome Measures :
  1. Narcotic utilization [ Time Frame: From time of consent until hospital discharge (3 days) ]

    total narcotic utilization measured with Morphine Equivalent Score

    The conversion scale being used will be the Center for Disease Control and Prevention Morphine Equivalent Score. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf

    Lower scores represent less opioid use and a better outcome. Higher scores represent more opioid use and a worse outcome.



Secondary Outcome Measures :
  1. Flatus [ Time Frame: From time of consent until hospital discharge (3 days) ]
    First return to bowel function

  2. Pain [ Time Frame: From time of consent until hospital discharge (3 days) ]
    Pain via a postoperative pain scale. This is a visual analog scale from 0 to 100. The patient will select a point on the scale indicating the level of pain they are feeling or felt in the indicated period. The number 0 indicates no pain, and 100 indicates the worst pain possible and felt in the period.

  3. Patient Satisfaction [ Time Frame: From time of consent until hospital discharge (3 days) ]
    Patient satisfaction will be assessed using the validated survey used in the Mayo Clinic Trial

  4. Postoperative complications during inpatient stay [ Time Frame: From time of consent until hospital discharge (3 days) ]
  5. Length of Stay [ Time Frame: Up to 3 days ]
    From time of consent until hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled to undergo a cesarean section

Exclusion Criteria:

  • Existing diagnosis of chronic pain
  • Need to undergo a vertical skin incision
  • AST > 50; ALT > 70
  • Platelets below 80,000 on admission
  • Need to undergo general anesthesia
  • Tubal ligation at time of Cesarean section
  • Prior or known allergy to any of the medications being utilized in this study

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): NCT03330119


Locations
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United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Brest, Norman A., M.D.
Investigators
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Principal Investigator: Norman Brest, MD

Additional Information:
Publications:
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Responsible Party: Norman A. Brest, Principle Investigator, Brest, Norman A., M.D.
ClinicalTrials.gov Identifier: NCT03330119     History of Changes
Other Study ID Numbers: F/N-R17-3732L
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Norman A. Brest, Brest, Norman A., M.D.:
Pregnancy
cesarean section
enhanced recovery
narcotic use