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

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ClinicalTrials.gov Identifier: NCT01741259
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Christy L Morgan, MD, Mercy Research

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Meperidine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
Study Start Date : August 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arm Intervention/treatment
Experimental: Meperidine PCEA
Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.
Drug: Meperidine
Other Name: Demerol

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
Drug: Meperidine
Other Name: Demerol




Primary Outcome Measures :
  1. Verbal Pain Score With Movement [ Time Frame: 36-48 hours post-op (until epidural is stopped) ]
    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.


Secondary Outcome Measures :
  1. Nausea and Vomiting [ Time Frame: 36-48 hours post-op (until epidural is stopped) ]
    The incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.

  2. Pruritus [ Time Frame: 36-48 hours post-op (until the epidural is stopped) ]
    The incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.

  3. Dysphoria [ Time Frame: 36-48 hours post-op (until epidural is stopped) ]
    The 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.

  4. Inadequate Analgesia [ Time Frame: 36-48 hours post-op (until the epidural is stopped) ]
    Patients 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.

  5. Adverse Outcomes [ Time Frame: 36-48 hours post-op (until the epidural is stopped) ]
    Adverse 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.

  6. Total Drug Dose [ Time Frame: 48 hours post-op or when the epidural is stopped ]
    Pharmacy will generate a report of the drug total from the pump on return to pharmacy.

  7. American Pain Society Patient Outcome Questionnaire #1 [ Time Frame: Survey day epidural stopped ]
    Please 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.

  8. American Pain Society Patient Outcome Questionnaire #2 [ Time Frame: Survey day epidural stopped ]
    On 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.

  9. American Pain Society Patient Outcome Questionnaire #3 [ Time Frame: Survey day epidural stopped ]
    How 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.

  10. American Pain Society Patient Outcome Questionnaire #4a [ Time Frame: Survey day epidural stopped ]
    How 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.

  11. American Pain Society Patient Outcome Questionnaire #4b [ Time Frame: Survey day epidural stopped ]
    How 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.

  12. American Pain Society Patient Outcome Questionnaire #4c [ Time Frame: Survey day epidural stopped ]
    How 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.

  13. American Pain Society Patient Outcome Questionnaire #4d [ Time Frame: Survey day epidural stopped ]
    How 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.

  14. American Pain Society Patient Outcome Questionnaire #5a [ Time Frame: Survey day epidural stopped ]
    On 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.

  15. American Pain Society Patient Outcome Questionnaire #5b [ Time Frame: Survey day epidural stopped ]
    On 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.

  16. American Pain Society Patient Outcome Questionnaire #5c [ Time Frame: Survey day epidural stopped ]
    How 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.

  17. American Pain Society Patient Outcome Questionnaire #5d [ Time Frame: Survey day epidural stopped ]
    How 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.

  18. American Pain Society Patient Outcome Questionnaire #6a [ Time Frame: Survey day epidural stopped ]
    On 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.

  19. American Pain Society Patient Outcome Questionnaire #6b [ Time Frame: Survey day epidural stopped ]
    On 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.

  20. American Pain Society Patient Outcome Questionnaire #6c [ Time Frame: Survey day epidural stopped ]
    On 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.

  21. American Pain Society Patient Outcome Questionnaire #6d [ Time Frame: Survey day epidural stopped ]
    On 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.

  22. American Pain Society Patient Outcome Questionnaire #7 [ Time Frame: Survey day epidural stopped ]
    Select 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.

  23. American Pain Society Patient Outcome Questionnaire #8 [ Time Frame: Survey day epidural stopped ]
    On 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.

  24. American Pain Society Patient Outcome Questionnaire #9 [ Time Frame: Survey day epidural stopped ]
    On 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741259


Locations
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United States, Missouri
Mercy Hospital St. Louis
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Mercy Research
Investigators
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Principal Investigator: Christy L Morgan, MD Mercy Hospital St. Louis

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Responsible Party: Christy L Morgan, MD, Obstetric Anesthesiologist, Mercy Research
ClinicalTrials.gov Identifier: NCT01741259     History of Changes
Other Study ID Numbers: 371047-1
First Posted: December 4, 2012    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christy L Morgan, MD, Mercy Research:
analgesia
meperidine
epidural
Additional relevant MeSH terms:
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Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia