Clinical trial NCT01741259: A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
Official title: A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: analgesia
meperidine
epidural
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 273
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria are as follows:

* 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

Primary outcomes:
measure: Verbal Pain Score With Movement
timeFrame: 36-48 hours post-op (until epidural is stopped)
Secondary outcomes:
measure: Nausea and Vomiting
timeFrame: 36-48 hours post-op (until epidural is stopped)
measure: Pruritus
timeFrame: 36-48 hours post-op (until the epidural is stopped)
measure: Dysphoria
timeFrame: 36-48 hours post-op (until epidural is stopped)
measure: Inadequate Analgesia
timeFrame: 36-48 hours post-op (until the epidural is stopped)
measure: Adverse Outcomes
timeFrame: 36-48 hours post-op (until the epidural is stopped)
measure: Total Drug Dose
timeFrame: 48 hours post-op or when the epidural is stopped
measure: American Pain Society Patient Outcome Questionnaire #1
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #2
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #3
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #4a
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #4b
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #4c
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #4d
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #5a
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #5b
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #5c
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #5d
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #6a
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #6b
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #6c
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #6d
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #7
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #8
timeFrame: Survey day epidural stopped
measure: American Pain Society Patient Outcome Questionnaire #9
timeFrame: Survey day epidural stopped
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
Study officials:
affiliation: Mercy Hospital St. Louis
name: Christy L Morgan, MD
role: PRINCIPAL_INVESTIGATOR
References: