Who is sponsoring PIEBvsPCEA?

PIEBvsPCEA is sponsored by Hospital del Rio Hortega.

What condition does PIEBvsPCEA study?

PIEBvsPCEA studies Anesthesia, Obstetrical, Analgesia, Epidural.

What drugs are being tested in PIEBvsPCEA?

Interventions: PIEB: Patient Intermittent Epidural Boluses, PCEA: Patient Controlled Epidural Analgesia.

What is the status of PIEBvsPCEA?

PIEBvsPCEA is currently COMPLETED.

Last reviewed 2018-08-02 · How we verify

Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine (PIEBvsPCEA)

NCT03133091 Phase 3 COMPLETED

Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

Details

Lead sponsor	Hospital del Rio Hortega
Phase	Phase 3
Status	COMPLETED
Enrolment	200
Start date	2015-09
Completion	2017-09

Conditions

Anesthesia, Obstetrical
Analgesia, Epidural

Interventions

PIEB: Patient Intermittent Epidural Boluses
PCEA: Patient Controlled Epidural Analgesia

Primary outcomes

VAS — 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery
Change from baseline in Visual Analog Scale

Countries

Spain