Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Laboring Women Requesting Neuraxial Labor Analgesia

Treatments: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02008591

2013P001927

Details and patient eligibility

About

The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.

The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia

Exclusion criteria

• 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.

5. Evidence of anticipated fetal anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Epidural Technique

Active Comparator group

Description:

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min

Treatment:

Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Combined Spinal Epidural Technique

Active Comparator group

Description:

Bupivacaine 2.5 mg with Fentanyl 25 mcg

Treatment:

Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Dural Puncture Epidural Technique

Active Comparator group

Description:

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min

Treatment:

Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique