Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients (PCEA)

Maimonides Medical Center

Status: Terminated

Conditions: LABOR PAIN

Study type: Observational

Funder types: Other

Identifiers

NCT03566342

IRB #08/08/VA07

Details and patient eligibility

About

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

Full 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.

Enrollment: 145 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

145 participants in 5 patient groups

GROUP A

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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