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 2.5ml of Bupivacaine 0.25% Plus Fentanyl 8 mcg/ml

NCT03735771 | Completed

• 1 other identifier: 18-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Programmed intermittent epidural bolus (PIEB) is a technique of epidural analgesia in which boluses of local anesthetic solutions are injected into the epidural space at a fixed time interval. Despite the increasingly popular use of PIEB for labor analgesia, the optimum regimen of drug delivery has yet to be determined. The outcomes of a chosen regimen will depend on the local anesthetic solution used (drug, concentration and mass) and the parameters established for the PIEB, typically associated with patient controlled epidural analgesia (PCEA). Also, the optimum regimen will depend on the anesthetic and obstetric outcomes of interest. The investigators have conducted several studies aiming at establishing the optimum PIEB regimen for the patient population at Mount Sinai Hospital. High sensory block levels obtained in some of the previous studies conducted at Mount Sinai Hospital and in other studies in the literature, in spite of not determining adverse effects, suggest an imperfect use of the technique, with an exaggerated and unnecessary spread of the epidural mixture. It is possible that by limiting the spread of the local anesthetic mixture, better analgesia can be provided with less overall consumption of local anesthetic. The investigators wanted to conduct a study using boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 mcg/mL. This would maintain the same dose of local anesthetic used in previous studies, but in a much smaller volume. This concentration and volume of bupivacaine has not been tried before as a PIEB regimen. The hypothesis of this study is that the optimum interval time between PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 mcg/ml will be between 30 and 60 minutes.

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 (1)

• Sensory block level

  6 hours

Other Outcomes (3)

• Motor block level assessed using Bromage score

  6 hours

• Pain score

  6 hours

• Hypotension

  6 hours

Study Arms (4)

60 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml. A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.

Drug: Bupivacaine

50 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml. A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.

Drug: Bupivacaine

40 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml. A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.

Drug: Bupivacaine

30 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml. A PCEA bolus of 2.5mL of 0.25% Bupivacaine plus fentanyl 8mcg/ml will also be available.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

0.25% bupivacaine plus fentanyl 8 mcg/ml

Also known as: Marcaine

30 minutes; 40 minutes; 50 minutes; 60 minutes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists Physical Status II or III
• Full term (greater than or equal to 37 weeks gestation)
• Nulliparous
• Singleton pregnancy, vertex presentation
• Active labor defined as regular painful contractions occurring at 3-5 minutes and with progressive cervical ripening
• Verbal Numerical Pain Score (VNPS) greater than 5 at requesting epidural analgesia (VNPS 0-10)
• Cervical dilatation between 2 and 5 cm

You may not qualify if:

• Any contraindication to epidural anesthesia
• Accidental dural puncture
• Allergy or hypersensitivity to bupivacaine or fentanyl
• Use of pharmacological analgesics within the last 4 hours
• Patient refusal to participate in the trial

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Shatalin D, Arzola C, Downey K, Ye XY, Carvalho JCA. Programmed intermittent epidural bolus for labour analgesia during first stage of labour: a sequential allocation trial to determine the effective interval time between boluses of a fixed volume of 2.5 mL of bupivacaine 0.25% plus fentanyl 8 microg.mL-1. Can J Anaesth. 2021 May;68(5):653-660. doi: 10.1007/s12630-021-01922-6. Epub 2021 Feb 2.

  PMID: 33532993 DERIVED

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: November 7, 2018
• First Posted: November 8, 2018
• Study Start: December 3, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)