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

NCT ID: NCT01741259

Last Updated: 2017-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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The objective of this study is to compare the efficacy, patient satisfaction, and incidence of side effects of meperidine patient-controlled epidural analgesia (PCEA) with and without a basal infusion for post-cesarean section analgesia.

Conditions

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Cesarean Section

Keywords

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analgesia meperidine epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Meperidine PCEA

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

Group Type EXPERIMENTAL

Meperidine

Intervention Type DRUG

Meperidine PCEA with basal

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

Group Type EXPERIMENTAL

Meperidine

Intervention Type DRUG

Interventions

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Meperidine

Intervention Type DRUG

Other Intervention Names

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Demerol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mercy Research

OTHER

Sponsor Role lead

Responsible Party

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Christy L Morgan, MD

Obstetric Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christy L Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital St. Louis

Locations

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Mercy Hospital St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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371047-1

Identifier Type: -

Identifier Source: org_study_id