Cesarean SectionNCT01741259
A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
A study testing Meperidine in people with Cesarean Section, run by Mercy Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Meperidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over the age of 18
- Undergoing non-urgent, non-emergent cesarean section at Mercy Hospital St. Louis
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- Meperidine
- Keywords
- analgesia, meperidine, epidural
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeperidineDrug
Also called Demerol
| Study group | Role | What they receive |
|---|---|---|
| Meperidine PCEA | Experimental | Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. Receives: Drug: Meperidine |
| Meperidine PCEA with basal | Experimental | Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg Receives: Drug: Meperidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36-48 hours post-op (until epidural is stopped)
Secondary outcomes (24)
Nausea and Vomiting
The incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.
Measured: 36-48 hours post-op (until epidural is stopped)
Pruritus
The incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.
Measured: 36-48 hours post-op (until the epidural is stopped)
Dysphoria
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.
Measured: 36-48 hours post-op (until epidural is stopped)
Inadequate Analgesia
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.
Measured: 36-48 hours post-op (until the epidural is stopped)
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.
Measured: 36-48 hours post-op (until the epidural is stopped)
Total Drug Dose
Pharmacy will generate a report of the drug total from the pump on return to pharmacy.
Measured: 48 hours post-op or when the epidural is stopped
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #2
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #3
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4a
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4b
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4c
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4d
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5a
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5b
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5c
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5d
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6a
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6b
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6c
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6d
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #7
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #8
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.
Measured: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #9
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.
Measured: Survey day epidural stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christy L Morgan, MD, Mercy Research
- Investigators
- Christy L Morgan, MD, Principal investigator, Mercy Hospital St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741259
- Sponsor's protocol ID
- 371047-1
- Status last verified
- Sep 2017
- First submitted
- 30 Nov 2012
- Last updated
- 25 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus
- ClinicalTrials.gov ID
- NCT01741259
- Acronym / sponsor ID
- 371047-1
- Conditions
- Cesarean Section
- Keywords
- analgesia, meperidine, epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 25 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meperidine PCEA | Experimental | Drug: MeperidineEpidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. |
| Meperidine PCEA with basal | Experimental | Drug: MeperidineEpidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Over the age of 18
- Undergoing non-urgent, non-emergent cesarean section at Mercy Hospital St. Louis
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeperidineAlso: Demerol | Drug | Meperidine PCEA, Meperidine PCEA with basal |
Primary outcome
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.
24 secondary outcomes
Nausea and Vomiting
Time frame: 36-48 hours post-op (until epidural is stopped)
Pruritus
Time frame: 36-48 hours post-op (until the epidural is stopped)
Dysphoria
Time frame: 36-48 hours post-op (until epidural is stopped)
Inadequate Analgesia
Time frame: 36-48 hours post-op (until the epidural is stopped)
Adverse Outcomes
Time frame: 36-48 hours post-op (until the epidural is stopped)
Total Drug Dose
Time frame: 48 hours post-op or when the epidural is stopped
American Pain Society Patient Outcome Questionnaire #1
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #2
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #3
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4a
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4b
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4c
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #4d
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5a
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5b
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5c
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #5d
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6a
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6b
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6c
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #6d
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #7
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #8
Time frame: Survey day epidural stopped
American Pain Society Patient Outcome Questionnaire #9
Time frame: Survey day epidural stopped
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy L Morgan, MD principal investigator
Mercy Hospital St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meperidine in people with Cesarean Section, run by Mercy Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Pain Score With Movement (time frame: 36-48 hours post-op (until epidural is stopped)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.