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

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.

Conditions

• Pregnancy Related
• Narcotic Use

Interventions

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.

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.

Sponsors & Collaborators

• Brest, Norman A., M.D.

  lead OTHER

Principal Investigators

• Norman Brest, MD

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-04

Primary Completion

2018-06-20

Completion

2018-06-20

FDA Drug

Yes

Countries

• United States

Study Locations