Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

University of British Columbia

Status and phase: Completed; Phase 4

Conditions: Labor Pain

Treatments: Drug: Bupivacaine 0.08% - fentanyl 2mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT03712735

H18-02318

Details and patient eligibility

About

Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.

Full description

The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.

Enrollment: 390 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton, vertex presentations at term (37-42 weeks gestational age)
• </= 5cm cervical dilation at the time of epidural anesthesia request
• ASA 2-3 patients aged 19 or over who are able to provide informed consent

Exclusion criteria

• Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
• History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
• Current or historical evidence of any significant medical conditions
• Clinical settings in which continuous epidural infusion may be preferable
• Risk factors significantly increasing the need for Cesarean delivery
• Anticipated fetal abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 3 patient groups

Group A

Active Comparator group

Description:

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min

Treatment:

Drug: Bupivacaine 0.08% - fentanyl 2mcg

Group B

Experimental group

Description:

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min

Treatment:

Drug: Bupivacaine 0.08% - fentanyl 2mcg

Group C

Experimental group

Description:

Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min

Treatment:

Drug: Bupivacaine 0.08% - fentanyl 2mcg