Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

NCT ID: NCT03566342

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2015-07-31

Brief Summary

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To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients.

Detailed Description

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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

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LABOR PAIN

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Parturients receiving Combined Spinal epidural analgesia for labor pain relief.

Exclusion Criteria

Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study.
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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kalpana tyagaraj

Residency Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KALPANA TYAGARAJ

Role: PRINCIPAL_INVESTIGATOR

MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219

Other Identifiers

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IRB #08/08/VA07

Identifier Type: -

Identifier Source: org_study_id

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