Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor-3

NCT02887222 | Completed

• 1 other identifier: 16-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Until recently, at Mount Sinai Hospital (MSH), 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 we should use intermittent programmed pushes. 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). Recently the epidural pumps at MSH were reprogrammed 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 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 excellent results were observed. However, in that study, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same interval of the previous study with smaller volumes of the intermittent boluses. Optimizing the technique, may allow the investigators to be able to reduce even further the amount of medication used by each patient. The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of women the necessary drug requirements during first stage of labor (EV90), thus avoiding breakthrough pain and need for PCEA or physician intervention. We hypothesize that this effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).

Conditions

Labor Pain

Keywords

Epidural; Labor analgesia; Programmed intermittent epidural bolus

Outcome Measures

Primary Outcomes (1)

• Adequate response of the patient, defined as no request for supplemental analgesia

  Adequate response of the patient, defined as 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

Secondary Outcomes (5)

• Sensory block level to ice

  6 hours

• Sensory block level to pin prick

  6 hours

• Motor block level assessed using Bromage score

  6 hours

• Hypotension

  6 hours

• Pain score

  6 hours

Study Arms (6)

PIEB volume of 7 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 7mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

PIEB volume of 8 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 8mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

PIEB volume of 9 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 9mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

PIEB volume of 10 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

PIEB volume of 11 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 11mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

PIEB volume of 12 mL

ACTIVE COMPARATOR

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 12mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

0.0625% Bupivacaine plus fentanyl 2mcg/ml

Also known as: Marcaine

PIEB volume of 10 mL; PIEB volume of 11 mL; PIEB volume of 12 mL; PIEB volume of 7 mL; PIEB volume of 8 mL; PIEB volume of 9 mL

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA 2 or 3
• ≥ 37 weeks gestation
• nulliparous
• Singleton pregnancy, vertex presentation
• Active labor: regular painful contractions occurring at 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

You may not qualify if:

• Refusal to provide written informed consent
• Patients unable to communicate fluently in English
• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 2, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)