A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus

NCT01741259 | Completed Results DMC

• 1 other identifier: 371047-1
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if epidural meperidine administered by patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled bolus.

Conditions

Cesarean Section

Keywords

analgesia; meperidine; epidural

Outcome Measures

Primary Outcomes (1)

• Verbal Pain Score With Movement

  Verbal Pain Score on a 0-10 scale is recorded by the nurse at 0, 4, 8, 12, 16, 20, 24, 28, 32, 36,40, 44, and 48 hours after transfer to the post-partum floor. On this scale, 0 represents no pain at all and 10 represents the worst pain imaginable. Because we were relying on nurses to capture this data in the course of normal patient care, scores within 1 hour before or after the goal time were accepted. For each patient, the average of all pain scores was taken and this was considered to be the average pain score while the epidural meperidine was being given.

  36-48 hours post-op (until epidural is stopped)

Secondary Outcomes (24)

• Nausea and Vomiting

  36-48 hours post-op (until epidural is stopped)

• Pruritus

  36-48 hours post-op (until the epidural is stopped)

• Dysphoria

  36-48 hours post-op (until epidural is stopped)

• Inadequate Analgesia

  36-48 hours post-op (until the epidural is stopped)

• Adverse Outcomes

  36-48 hours post-op (until the epidural is stopped)

Study Arms (2)

Meperidine PCEA

EXPERIMENTAL

Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.

Drug: Meperidine

Meperidine PCEA with basal

EXPERIMENTAL

Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg

Drug: Meperidine

Interventions

Meperidine DRUG

Also known as: Demerol

Meperidine PCEA; Meperidine PCEA with basal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Over the age of 18
• Undergoing non-urgent, non-emergent cesarean section at Mercy Hospital St. Louis

You may not qualify if:

• non-English speaking
• mentally disabled
• allergy to meperidine
• seizure disorder
• renal impairment defined as a serum creatinine \>0.8 mg/dL or patients who give a history of renal impairment
• fever greater than 101
• patients receiving low molecular weight heparin at any dose or unfractionated heparin at doses greater than 5000 u subcutaneous twice daily
• pre-eclampsia requiring magnesium due to post-partum room assignment
• obstructive sleep apnea due to post-partum room assignment
• post-partum hemorrhage due to post-partum room assignment

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Meperidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Christy Morgan, MD
• Organization: OB Anesthesia Associates

christylmorganmd@gmail.com

314-469-6800

Study Officials

• Christy L Morgan, MD

  Mercy Hospital St. Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetric Anesthesiologist

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: August 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 25, 2017
• Results First Posted: October 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)