NCT03330119

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,494

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

October 24, 2017

Results QC Date

January 18, 2021

Last Update Submit

March 1, 2021

Conditions

Pregnancy RelatedNarcotic Use

Keywords

Pregnancycesarean sectionenhanced recoverynarcotic use

Outcome Measures

Primary Outcomes (1)

  • Narcotic Utilization

    total narcotic utilization measured with Morphine Milligram Equivalent (MME) The conversion scale being used will be the Center for Disease Control and Prevention Morphine Equivalent Score. Lower scores represent less opioid use and a better outcome. Higher scores represent more opioid use and a worse outcome.

    From time of consent until hospital discharge (3 days)

Study Arms (2)

Alternate Management

EXPERIMENTAL
Drug: Alternate Management

Control

PLACEBO COMPARATOR

The regular Lankenau cesarean section order set.

Drug: Control

Interventions

Alternate ManagementDRUG

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.

Also known as: Enhanced Recovery
Alternate Management
ControlDRUG

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.

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Scheduled to undergo a cesarean section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (7)

  • Nelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.

    PMID: 25316179BACKGROUND

  • Moore A, Costello J, Wieczorek P, Shah V, Taddio A, Carvalho JC. Gabapentin improves postcesarean delivery pain management: a randomized, placebo-controlled trial. Anesth Analg. 2011 Jan;112(1):167-73. doi: 10.1213/ANE.0b013e3181fdf5ee. Epub 2010 Nov 16.

    PMID: 21081764BACKGROUND

  • Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

    PMID: 26977696BACKGROUND

  • Committee opinion no. 633: Alcohol abuse and other substance use disorders: ethical issues in obstetric and gynecologic practice. Obstet Gynecol. 2015 Jun;125(6):1529-1537. doi: 10.1097/01.AOG.0000466371.86393.9b.

    PMID: 26000541BACKGROUND

  • Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. doi: 10.1542/peds.2013-1985. Epub 2013 Aug 26.

    PMID: 23979084BACKGROUND

  • Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.

    PMID: 14622770BACKGROUND

  • Guttuso T Jr, Shaman M, Thornburg LL. Potential maternal symptomatic benefit of gabapentin and review of its safety in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:280-3. doi: 10.1016/j.ejogrb.2014.08.013. Epub 2014 Aug 17.

    PMID: 25195202BACKGROUND

Related Links

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Norman Brest
Organization
Main Line Health System
brestn@mlhs.org
484-476-2325

Study Officials

  • Norman Brest, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 6, 2017

Study Start

October 4, 2017

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

March 2, 2021

Results First Posted

March 2, 2021

Record last verified: 2021-03

Locations

US(1)