Trial Outcomes & Findings for A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus (NCT NCT01741259)

NCT ID: NCT01741259

Last Updated: 2017-10-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 273 participants
• Primary outcome timeframe: 36-48 hours post-op (until epidural is stopped)
• Results posted on: 2017-10-25

Participant Flow

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.

Participant milestones

Measure	Meperidine PCEA Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	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
Overall Study STARTED	133	135
Overall Study COMPLETED	127	129
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	Meperidine PCEA Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	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
Overall Study Protocol Violation	6	4
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine	Total n=256 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 4.39 • n=5 Participants	31 years STANDARD_DEVIATION 4.81 • n=7 Participants	31 years STANDARD_DEVIATION 4.60 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	129 Participants n=7 Participants	256 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants	129 participants n=7 Participants	256 participants n=5 Participants
Primary vs repeat Cesarean Section Primary CS	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Primary vs repeat Cesarean Section Repeat CS	90 Participants n=5 Participants	88 Participants n=7 Participants	178 Participants n=5 Participants
BMI	34.03 kg/m^2 STANDARD_DEVIATION 7.22 • n=5 Participants	32.18 kg/m^2 STANDARD_DEVIATION 6.17 • n=7 Participants	33.09 kg/m^2 STANDARD_DEVIATION 6.76 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Verbal Pain Score With Movement	1.92 units on a scale Standard Deviation 1.00	1.50 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Nausea and Vomiting	1 participants	3 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Pruritus	20 participants	10 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Dysphoria	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Inadequate Analgesia	7 participants	3 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Adverse Outcomes	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=127 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=129 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
Total Drug Dose	5.42 milligrams of drug per hour Standard Deviation 2.28	8.49 milligrams of drug per hour Standard Deviation 4.19

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #1	1.89 units on a scale Standard Error .152	1.45 units on a scale Standard Error .153

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #2	5.79 units on a scale Standard Error .175	5.10 units on a scale Standard Error .199

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #3	14.47 percentage of time Standard Error 1.778	11.78 percentage of time Standard Error 1.327

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=121 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=117 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #4a	4.04 units on a scale Standard Error .222	3.13 units on a scale Standard Error .203

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=120 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=114 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #4b	4.02 units on a scale Standard Error .235	3.71 units on a scale Standard Error .238

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #4c	2.016 units on a scale Standard Error .2171	1.487 units on a scale Standard Error .1853

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=117 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #4d	2.04 units on a scale Standard Error .210	1.68 units on a scale Standard Error .210

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #5a	1.311 units on a scale Standard Error .1965	1.504 units on a scale Standard Error .1808

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=117 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #5b	.47 units on a scale Standard Error .123	.34 units on a scale Standard Error .092

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=117 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #5c	.85 units on a scale Standard Error .171	.79 units on a scale Standard Error .154

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=117 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #5d	1.42 units on a scale Standard Error .227	1.49 units on a scale Standard Error .220

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #6a	.49 units on a scale Standard Error .110	.69 units on a scale Standard Error .143

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #6b	2.26 units on a scale Standard Error .211	2.91 units on a scale Standard Error .231

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=121 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #6c	2.661 units on a scale Standard Error .2557	2.419 units on a scale Standard Error .2537

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #6d	.84 units on a scale Standard Error .152	1.13 units on a scale Standard Error .176

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #7	77.05 percentage of pain relieved Standard Error 1.733	81.82 percentage of pain relieved Standard Error 1.592

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #8	8.996 units on a scale Standard Error .1932	9.258 units on a scale Standard Error .1547

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Meperidine PCEA n=122 Participants Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Meperidine	Meperidine PCEA With Basal n=118 Participants Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Meperidine
American Pain Society Patient Outcome Questionnaire #9	8.76 units on a scale Standard Error .183	9.41 units on a scale Standard Error .106

Adverse Events

Meperidine PCEA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Meperidine PCEA With Basal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christy Morgan, MD

OB Anesthesia Associates

Phone: 314-469-6800

Email: christylmorganmd@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place