Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2

NCT ID: NCT02758405

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-02-28

Brief Summary

Brief 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 investigators are currently using pumps set up with PIEB, in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. The investigators have recently concluded a study at MSH using PIEB where they observed excellent results. However, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same dose of the freezing medication, but using a smaller volume of local anesthetic at a higher concentration. This optimization may also further reduce the amount of medication used by each patient.

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 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.

Detailed Description

Studies involving programmed intermittent epidural bolus (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 patient controlled epidural anesthesia (PCEA) 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.

At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Based on previous research done by the investigators, the current epidural regimen consists of 10 ml PIEB at 40 minute intervals, 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 5mL PIEBs of bupivacaine 0.125% 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 using a higher concentration epidural mixture.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

60 minutes

The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Fentanyl

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Infusion pump

Intervention Type: DEVICE

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

50 minutes

The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Fentanyl

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Infusion pump

Intervention Type: DEVICE

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

40 minutes

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Fentanyl

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Infusion pump

Intervention Type: DEVICE

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

30 minutes

The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Fentanyl

Intervention Type: DRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Infusion pump

Intervention Type: DEVICE

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

Interventions

Bupivacaine

0.125% Bupivacaine plus fentanyl 2mcg/ml

Intervention Type: DRUG

Fentanyl

0.125% Bupivacaine plus fentanyl 2mcg/ml

Intervention Type: DRUG

Infusion pump

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

Intervention Type: DEVICE

Other Intervention Names

Marcaine; CADD-Solis Ambulatory Infusion Pump

Eligibility Criteria

Inclusion Criteria

• ASA 2 or 3
• Full term (≥ 37 weeks gestation)
• Nulliparous
• Singleton pregnancy, vertex presentation
• Active labor: regular painful contractions occurring at 3-at least every 5 minutes and change in cervix
• Verbal Numerical Pain Score (VNPS) at requesting analgesia > 5 (VNPS 0-10)
• Cervical dilatation ≥2 ≤ 5 cm

Exclusion Criteria

• Refusal to provide written informed consent.
• Any contraindication to epidural anesthesia
• Unintentional dural puncture
• Allergy or hypersensitivity to bupivacaine or fentanyl
• Use of opioids or sedatives within the last 4 hours.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

16-03

Identifier Type: -

Identifier Source: org_study_id