LABOR PAINPCEANCT03566342
Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients
An observational study of LABOR PAIN, run by Maimonides Medical Center.
Trial summary
To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- LABOR PAIN
- Type of treatment
- Injection or infusion
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2015
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Laboring women receiving combined spinal epidural analgesia for pain relief
Who may be able to join
- Parturients receiving Combined Spinal epidural analgesia for labor pain relief.
Who cannot join
- Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study.
About this study
Official title: Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients Receiving Combined Spinal and Epidural Analgesia (CSE)
To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients.
Read the detailed description
In this prospective trial, the investigators would like to examine the efficacy of several different PCEA protocols in 250 parturients who receive CSE for labor pain. Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study. Each patient will be assigned to one of five groups (A - E), depending on the day of admission for delivery, excluding Friday and Saturday (observed religious holidays). Each group will have 50 patients.
- Conditions
- LABOR PAIN
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 8ml Lockout ( number of doses per hour) 2 Lock out interval 30 minutes | |
| GROUP B | The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 5ml Lockout ( number of doses per hour) 4 Lock out interval 15 minutes | |
| GROUP C | The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 3ml Lockout ( number of doses per hour) 6 Lock out interval 10 minutes | |
| GROUP D | The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 14 ml/hour Demand dose 0 ml Lockout ( number of doses per hour) 0 Lock out interval 0 minutes | |
| GROUP E | The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 7ml Lockout ( number of doses per hour) 3 Lock out interval 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
From each patient investigators will collect pain scores to assess the severity of labor pain, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal pain and VAS score of 10 is considered as the maximum pain.
Measured: 24 to 48 hours.
Secondary outcomes (7)
Number of boluses
From each patient the investigators will obtain information on total number of boluses of the epidural medication used
Measured: 24 to 48 hours
Amount of medication used
From each patient the investigators will obtain information regarding the total amount of medications used in mls from reviewing the history on the PCEA pump.
Measured: 24 to 48 hours
Motor block
For each patient, the investigators will obtain information regarding degree of motor block using the Modified Bromage scale.
Modified Bromage score:
- Complete block (unable to move feet or knees)
- Almost complete block (able to move feet only)
- Partial block (just able to move knees)
- Detectable weakness of hip flexion while supine (full flexion of knees)
- No detectable weakness of hip flexion while supine
- Able to perform partial knee bend
Measured: 24 to 48 hours.
Height of the patient
From each patient the investigators will obtain information on height in inches.
Measured: At recruitment of the patient in to the study
Weight of the patient
From each patient the investigators will obtain information on weight in pounds
Measured: At recruitment of the patient in to the study
Overall patient satisfaction
From each patient investigators will collect satisfaction scores to assess degree of satisfaction, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal satisfaction and VAS score of 10 is considered as the maximum satisfaction.
Measured: 24 to 48 hours
Mode of delivery
From each patient the investigators will obtain information regarding mode of delivery- vaginal delivery or C-Section
Measured: 24 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study startAug 2007
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Preliminary analysis of data showed no significant findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LABOR PAINStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kalpana tyagaraj, Maimonides Medical Center
- Investigators
- KALPANA TYAGARAJ, Principal investigator, MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566342
- Sponsor's protocol ID
- IRB #08/08/VA07
- Acronym
- PCEA
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients Receiving Combined Spinal and Epidural Analgesia (CSE)
- ClinicalTrials.gov ID
- NCT03566342
- Acronym / sponsor ID
- PCEA / IRB #08/08/VA07
- Conditions
- LABOR PAIN
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary analysis of data showed no significant findings
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients.
Detailed description
In this prospective trial, the investigators would like to examine the efficacy of several different PCEA protocols in 250 parturients who receive CSE for labor pain. Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study. Each patient will be assigned to one of five groups (A - E), depending on the day of admission for delivery, excluding Friday and Saturday (observed religious holidays). Each group will have 50 patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GROUP A | – | –The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 8ml Lockout ( number of doses per hour) 2 Lock out interval 30 minutes |
| GROUP B | – | –The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 5ml Lockout ( number of doses per hour) 4 Lock out interval 15 minutes |
| GROUP C | – | –The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 3ml Lockout ( number of doses per hour) 6 Lock out interval 10 minutes |
| GROUP D | – | –The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 14 ml/hour Demand dose 0 ml Lockout ( number of doses per hour) 0 Lock out interval 0 minutes |
| GROUP E | – | –The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 7ml Lockout ( number of doses per hour) 3 Lock out interval 20 minutes |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Laboring women receiving combined spinal epidural analgesia for pain relief
Key inclusion criteria (1 listed)
- Parturients receiving Combined Spinal epidural analgesia for labor pain relief.
Key exclusion criteria (1 listed)
- Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores
Time frame: 24 to 48 hours.
From each patient investigators will collect pain scores to assess the severity of labor pain, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal pain and VAS score of 10 is considered as the maximum pain.
7 secondary outcomes
Number of boluses
Time frame: 24 to 48 hours
Amount of medication used
Time frame: 24 to 48 hours
Motor block
Time frame: 24 to 48 hours.
Height of the patient
Time frame: At recruitment of the patient in to the study
Weight of the patient
Time frame: At recruitment of the patient in to the study
Overall patient satisfaction
Time frame: 24 to 48 hours
Mode of delivery
Time frame: 24 to 48 hours
Results and safety
The study was stopped early (reason given: Preliminary analysis of data showed no significant findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
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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.
KALPANA TYAGARAJ principal investigator
MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219
Questions about this trial
What is this clinical trial studying?
An observational study of LABOR PAIN, run by Maimonides Medical Center.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Preliminary analysis of data showed no significant findings). Results are not available in the source record.
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?
Pain scores (time frame: 24 to 48 hours.). 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 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.