Does the Volume of Medication Affect the Success of Labor Epidural Analgesia

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBeth Israel Deaconess Medical Center

About this trial

The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Gestational age of 36 weeks or greater

American Society of Anesthesiology physical status 2

Induction of labor or early labor (cervical dilation < 6cm)

Disqualifiers

Preeclampsia

Receiving magnesium sulfate

Having received narcotics within 4 hours

Multiple gestation

Trial design

Design model

Parallel

Treatments tested in this trial

  • administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes

    Drug

    Dose of medication delivered using a programmed intermittent epidural bolus

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: High volume low concentrationActive comparator 1 intervention
Group B: Low concentration high volumeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient controlled boluses received

The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief

Time frame
The duration of labor until delivery of the neonate

Secondary outcomes

1

Patient controlled boluses requests

The number of patient controlled boluses requested by pressing the PCA button for additional pain relief

Time frame
The duration of labor until delivery of the neonate
2

Physician administered epidural bolus

The number of times that a physician supplies additional medication for the control of pain

Time frame
The duration of labor until delivery of the neonate

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: