Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion, intermittent programmed pushes should be used. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). The new pumps are able to deliver bolus of medication at regular intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. Based on the information already available in the literature, this study aims to determine the best regimen of PIEB achievable with our standard epidural mixture.

The hypothesis of this study is that there is an optimal interval time between PIEB boluses of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Treatments: Bupivacaine; Fentanyl

Criteria

Inclusion Criteria:

• ASA I or II

• Full term (≥ 37 weeks gestation)

• nulliparous

• Singleton pregnancy, vertex presentation

• Regular painful contractions occurring at least every 5 minutes

• VAS Pain score at requesting analgesia > 5 (VNPS 0-10)

• Cervical dilatation < 5 cm

Exclusion Criteria:

• Refusal to provide written informed consent.

• Any contraindication to epidural anesthesia

• Accidental dural puncture

• Allergy or hypersensitivity to bupivacaine or fentanyl

• Use of opioids or sedatives within the last 4 hours.