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

Labor Pain Clinical Trial

Official title:

Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 ml of Bupivacaine 0.0625% Plus Fentanyl 2 mcg/ml.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550262
• Other study ID #: 15-01
• Status: Completed
• Phase: N/A
• First received: September 2, 2015
• Last updated: May 2, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

All studies involving PIEB to date have provided an analgesic regimen that delivered an amount of local anesthetic that was below the patient's requirement per hour, as the studies were done in the context of an association with PCEA (Patient controlled epidural anesthesia) as a rescue technique. As a result, PCEA requests were frequent and therefore these studies have not been able to truly understand the pharmacology of the bolus technique in the PIEB regimen, as the PCEA utilized by patients added an extra component to the regimen.

The ideal volume and interval time between PIEB bolus has not yet been established in the literature. Most likely the ideal volume and interval time between PIEB bolus will be specific for each epidural mixture.

At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Our current epidural regimen consists of 10 ml continuous infusion per hour, with PCEA boluses of 5 ml and a lock out interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour. In this study, the investigators will offer patients 10mL PIEBs of bupivacaine 0.0625% with fentanyl 2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB regimen that will be effective for our patient population with our standard epidural mixture.

Finding the best way of using the new device that will be able to provide analgesia for 90% of the parturients will represent a great improvement in labor analgesia. Moreover, there are expectations of having fewer side effects since the PIEB is more effective than CEI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Bupivacaine
0.0625% Bupivacaine plus fentanyl 2mcg/ml
• Fentanyl
0.0625% Bupivacaine plus fentanyl 2mcg/ml

Device:
• Infusion pump
Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No request for supplemental analgesia	No request for supplemental analgesia (PCEA bolus or clinician administered bolus) until the completion of the first stage of labor or until 6 hours following initiation of the programmed intermittent epidural bolus (PIEB).	6 hours	No
Secondary	Sensory block level	Sensory block to ice will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient still does not feel cold sensation as compared to a control site (frontal part of the head)	6 hours	No
Secondary	Motor block level assessed using Bromage score	Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.	6 hours	No
Secondary	Hypotension	A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural).	6 hours	No
Secondary	Pain score	Pain score measured hourly using VNRS (0-10)	6 hours	No