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

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Conditions

Labor Pain

Treatments

Device: Infusion pump
Drug: Fentanyl
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02758405
16-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

16 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups

60 minutes
Experimental group
Description:
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.
Treatment:
Drug: Fentanyl
Drug: Bupivacaine
Device: Infusion pump
50 minutes
Experimental group
Description:
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.
Treatment:
Drug: Fentanyl
Drug: Bupivacaine
Device: Infusion pump
40 minutes
Experimental group
Description:
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.
Treatment:
Drug: Fentanyl
Drug: Bupivacaine
Device: Infusion pump
30 minutes
Experimental group
Description:
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.
Treatment:
Drug: Fentanyl
Drug: Bupivacaine
Device: Infusion pump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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