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

ClinicalTrials.gov ID NCT01741259
Sponsor Mercy Research
Information provided by Christy L Morgan, MD, Mercy Research (Responsible Party)
Last Update Posted 2017-10-25
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Study Overview

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.
Official Title
A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
Conditions
Cesarean Section
Intervention / Treatment
  • Drug: Meperidine
  • Drug: Meperidine
Other Study ID Numbers
  • 371047-1
Study Start
2013-08
Primary Completion (Actual)
2015-04
Study Completion (Actual)
2015-04
Enrollment (Actual)
273
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Missouri Locations
Saint Louis, Missouri, United States, 63141

Mercy Hospital St. Louis
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
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Ages Eligible for Study
18 Years to 50 Years (Adult )
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Meperidine PCEA
Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.
Intervention/Treatment Drug: Meperidine
  • Other Names:
    • Demerol
Participant Group/Arm Experimental: Meperidine PCEA with basal
Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg
Intervention/Treatment Drug: Meperidine
  • Other Names:
    • Demerol
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Verbal Pain Score With MovementVerbal 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 Outcome Measures
Outcome Measure Measure Description Time Frame
Nausea and VomitingThe incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.36-48 hours post-op (until epidural is stopped)
PruritusThe incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.36-48 hours post-op (until the epidural is stopped)
DysphoriaThe incidence of dysphoria will be captured when a nurse calls the anesthesia team to alert them. This information is tracked on the physician rounding sheet. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if dysphoria was the cause.36-48 hours post-op (until epidural is stopped)
Inadequate AnalgesiaPatients routinely get scheduled ibuprofen as an adjunct to the epidural infusion. The record will be reviewed to see if ketorolac is substituted for ibuprofen or other pain medications such as acetaminophen either alone or in combination with oxycodone or other narcotic pain relievers are administered. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if inadequate analgesia was the cause.36-48 hours post-op (until the epidural is stopped)
Adverse OutcomesAdverse outcomes such as seizures or respiratory depression will be reported to anesthesia personnel by nursing if they occur. Patients are monitored for respiratory rate and sedation every 1 hour for 24 hours, then every 2 hours for 24 hours. Pulse, blood pressure, and neurocirculatory checks are performed every 2 hours for 24 hours and then every 4 hours per our nursing protocol.36-48 hours post-op (until the epidural is stopped)
Total Drug DosePharmacy will generate a report of the drug total from the pump on return to pharmacy.48 hours post-op or when the epidural is stopped
American Pain Society Patient Outcome Questionnaire #1Please indicate on 0-10 scale the least pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #2On 0-10 scale, indicate the worst pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #3How often were you in severe pain in the first 24 hours (percentage 0-100%). 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4aHow much, on 0-10 scale, did pain interfere with doing activities in bed (turning, sitting up, repositioning) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4bHow much, on a 0-10 scale, did pain interfere with doing activities out of bed (walking, sitting in chair, standing at sink) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4cHow much, on a 0-10 scale, did pain interfere with falling asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4dHow much, on a scale of 0-10, did pain interfere with staying asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5aOn a scale of 0-10, how much did the pain cause you to feel anxious where 0 is not at all anxious and 10 is extremely anxious. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5bOn a scale of 0-10, how much did pain cause you to feel depressed where 0 is not al all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5cHow much, on a scale of 0-10, did the pain cause you to feel frightened where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5dHow much, on a scale of 0-10, did the pain cause you to feel helpless where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6aOn a scale of 0-10, what was the severity of your nausea where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6bOn a 0-10 scale, how severe was your drowsiness where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6cOn a 0-10 scale, how severe was your itching where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6dOn a 0-10 scale, how severe was your dizziness where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #7Select the percentage (from 0%-100%) of pain relief you received from all medical and non-medical treatments in the first 24 hours. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #8On a 0-10 scale, were you allowed to participate in decisions about your pain treatment as much as you wanted to with 0 being not at all and 10 being entirely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #9On a 0-10 scale, how satisfied are you with the results of your pain treatment with 0 being extremely dissatisfied and 10 being extremely satisfied. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.Survey day epidural stopped

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Mercy Research
Investigators
  • Principal Investigator:Christy L Morgan, MD,Mercy Hospital St. Louis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2012-11-30
First Submitted that Met QC Criteria
2012-11-30
First Posted (Estimated)
2012-12-04
Results Reporting Dates
Results First Submitted
2017-03-25
Results First Submitted that Met QC Criteria
2017-09-25
Results First Posted
2017-10-25
Study Record Updates
Last Update Submitted that met QC Criteria
2017-09-25
Last Update Posted
2017-10-25
Last Verified
2017-09

More Information

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Keywords Provided by Christy L Morgan, MD, Mercy Research
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No