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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741259

Enrollment

273

Registered

2012-12-04

Start date

2013-08-31

Completion date

2015-04-30

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

analgesia, meperidine, epidural

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.

Interventions

DRUGMeperidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Verbal Pain Score With Movement	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

Measure	Time frame	Description
Pruritus	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.
Dysphoria	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.
Inadequate Analgesia	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.
Adverse Outcomes	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.
Total Drug Dose	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.
American Pain Society Patient Outcome Questionnaire #1	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.
American Pain Society Patient Outcome Questionnaire #2	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.
American Pain Society Patient Outcome Questionnaire #3	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.
American Pain Society Patient Outcome Questionnaire #4a	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.
American Pain Society Patient Outcome Questionnaire #4b	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.
American Pain Society Patient Outcome Questionnaire #4c	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.
Nausea and Vomiting	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.
American Pain Society Patient Outcome Questionnaire #5a	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.
American Pain Society Patient Outcome Questionnaire #5b	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.
American Pain Society Patient Outcome Questionnaire #5c	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.
American Pain Society Patient Outcome Questionnaire #5d	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.
American Pain Society Patient Outcome Questionnaire #6a	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.
American Pain Society Patient Outcome Questionnaire #6b	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.
American Pain Society Patient Outcome Questionnaire #6c	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.
American Pain Society Patient Outcome Questionnaire #6d	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.
American Pain Society Patient Outcome Questionnaire #7	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.
American Pain Society Patient Outcome Questionnaire #8	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.
American Pain Society Patient Outcome Questionnaire #9	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.
American Pain Society Patient Outcome Questionnaire #4d	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.

Countries

United States

Participant flow

Pre-assignment details

5 Patients were excluded after enrollment but prior to randomization. 3 were due to not having an epidural in place after surgery - 2 had accidental intrathecal catheter placement and 1 was to be started on lovenox. Another had a missing consent form and the other was started on magnesium sulfate which was an exclusion criterion.

Participants by arm

Arm	Count
Meperidine PCEA Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	127
Meperidine PCEA With Basal Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine	129
Total	256

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	6	4
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Meperidine PCEA	Meperidine PCEA With Basal	Total
Age, Continuous	31 years STANDARD_DEVIATION 4.39	31 years STANDARD_DEVIATION 4.81	31 years STANDARD_DEVIATION 4.6
BMI	34.03 kg/m^2 STANDARD_DEVIATION 7.22	32.18 kg/m^2 STANDARD_DEVIATION 6.17	33.09 kg/m^2 STANDARD_DEVIATION 6.76
Primary vs repeat Cesarean Section Primary CS	37 Participants	41 Participants	78 Participants
Primary vs repeat Cesarean Section Repeat CS	90 Participants	88 Participants	178 Participants
Region of Enrollment United States	127 participants	129 participants	256 participants
Sex: Female, Male Female	127 Participants	129 Participants	256 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 127	0 / 129
other Total, other adverse events	0 / 127	0 / 129
serious Total, serious adverse events	0 / 127	0 / 129

Outcome results

Primary

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.

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

Arm	Measure	Value (MEAN)	Dispersion
Meperidine PCEA	Verbal Pain Score With Movement	1.92 units on a scale	Standard Deviation 1
Meperidine PCEA With Basal	Verbal Pain Score With Movement	1.50 units on a scale	Standard Deviation 1.06

Secondary

Adverse Outcomes

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.

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

Arm	Measure	Value (NUMBER)
Meperidine PCEA	Adverse Outcomes	0 participants
Meperidine PCEA With Basal	Adverse Outcomes	0 participants

Secondary

American Pain Society Patient Outcome Questionnaire #1

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.