Trial · NCT01741259
A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
NCT01741259, Not applicable, Completed, Mercy Research; results first posted 2017-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus. Trials, record NCT01741259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01741259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
- NCT number
- NCT01741259
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 273 participants, actual
- Lead sponsor
- Mercy Research
- Conditions
- Cesarean Section
- Interventions
- Meperidine
- First posted
- 2012-12-04
- Last updated
- 2017-10-25
- Results first posted
- 2017-10-25
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Verbal Pain Score With Movement | 36-48 hours post-op (until epidural is stopped) | units on a scale | MEAN | |
| SECONDARY | Nausea and Vomiting | 36-48 hours post-op (until epidural is stopped) | participants | NUMBER | |
| SECONDARY | Pruritus | 36-48 hours post-op (until the epidural is stopped) | participants | NUMBER | |
| SECONDARY | Dysphoria | 36-48 hours post-op (until epidural is stopped) | participants | NUMBER | |
| SECONDARY | Inadequate Analgesia | 36-48 hours post-op (until the epidural is stopped) | participants | NUMBER | |
| SECONDARY | Adverse Outcomes | 36-48 hours post-op (until the epidural is stopped) | participants | NUMBER | |
| SECONDARY | Total Drug Dose | 48 hours post-op or when the epidural is stopped | milligrams of drug per hour | MEAN | |
| SECONDARY | American Pain Society Patient Outcome Questionnaire #1 | Survey day epidural stopped | units on a scale | MEAN | |
| SECONDARY | American Pain Society Patient Outcome Questionnaire #2 | Survey day epidural stopped | units on a scale | MEAN | |
| SECONDARY | American Pain Society Patient Outcome Questionnaire #3 | Survey day epidural stopped | percentage of time | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Verbal Pain Score With Movement | Meperidine PCEA | 1.92 | Standard Deviation 1.00 | units on a scale | |
| Verbal Pain Score With Movement | Meperidine PCEA With Basal | 1.50 | Standard Deviation 1.06 | units on a scale | |
| Nausea and Vomiting | Meperidine PCEA | 1 | participants | ||
| Nausea and Vomiting | Meperidine PCEA With Basal | 3 | participants | ||
| Pruritus | Meperidine PCEA | 20 | participants | ||
| Pruritus | Meperidine PCEA With Basal | 10 | participants | ||
| Dysphoria | Meperidine PCEA | 0 | participants | ||
| Dysphoria | Meperidine PCEA With Basal | 0 | participants | ||
| Inadequate Analgesia | Meperidine PCEA | 7 | participants | ||
| Inadequate Analgesia | Meperidine PCEA With Basal | 3 | participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Meperidine PCEA | 133 | |
| Overall Study | STARTED | Meperidine PCEA With Basal | 135 | |
| Overall Study | COMPLETED | Meperidine PCEA | 127 | |
| Overall Study | COMPLETED | Meperidine PCEA With Basal | 129 | |
| Overall Study | NOT COMPLETED | Meperidine PCEA | 6 | |
| Overall Study | NOT COMPLETED | Meperidine PCEA With Basal | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Meperidine PCEA | 0 | 127 |
| Total, all-cause mortality | Meperidine PCEA With Basal | 0 | 129 |
| Total, other adverse events | Meperidine PCEA | 0 | 127 |
| Total, other adverse events | Meperidine PCEA With Basal | 0 | 129 |
| Total, serious adverse events | Meperidine PCEA | 0 | 127 |
| Total, serious adverse events | Meperidine PCEA With Basal | 0 | 129 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Meperidine PCEA vs Meperidine PCEA With Basal: Dysphoria | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: Pruritus | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: Inadequate Analgesia | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: Adverse Outcomes | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: Nausea and Vomiting | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: deaths from any cause | Trial comparisons |
| Meperidine PCEA vs Meperidine PCEA With Basal: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01741259
GET https://conductscience.org/api/trials/v1/NCT01741259/registered?page=2