Drug Concentration and Volume on Adequate Labor Analgesia With PIEB

NCT03553576 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STU00206113
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

Conditions

Pain; Anesthesia; Labor Pain

Keywords

Labor pain; Epidural; Obstetric; Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Anesthesia Provider Administered Bolus

  Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.

  72 hours

Secondary Outcomes (14)

• VAS at 10 Centimeters Dilation of Cervix

  24 hours

• VAS Score After Delivery

  24 hours

• Intrascapular Pain

  72 hours

• Provider Administered Bolus

  72 hours

• Number of Participants Who Required Additional Provider Redoses

  72 hours

Study Arms (2)

Low volume bolus

EXPERIMENTAL

6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL)

Drug: Low volume bolus

High volume bolus

EXPERIMENTAL

10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

Drug: High volume bolus

Interventions

Low volume bolus DRUG

Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.

Low volume bolus

High volume bolus DRUG

Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.

High volume bolus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above
• Nulliparous parturients
• Present to the labor and delivery unit for an induction of labor or who are in spontaneous labor
• Request neuraxial labor analgesia at ≤5 cm cervical dilation

You may not qualify if:

• Patients who are not eligible to receive a combined spinal epidural (CSE) technique with 25 mcg of intrathecal fentanyl
• Non-English speaking
• Failed initiation of CSE analgesia (VAS pain score \>10 15 minutes after intrathecal dose)
• Need to have the epidural catheter replaced during labor
• Who deliver within 90 minutes of initiation of labor analgesia
• Require re-dose within 90 minutes of initiation of labor analgesia.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.

  PMID: 16492849 BACKGROUND

• Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004.

  PMID: 16154735 BACKGROUND

• Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.

  PMID: 15197122 BACKGROUND

• Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available.

  PMID: 10439786 BACKGROUND

• Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.

  PMID: 11915061 BACKGROUND

• Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.

  PMID: 11454372 BACKGROUND

MeSH Terms

Conditions

Pain; Labor Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

A larger study would need to evaluate the secondary outcomes as the current study was underpowered to evaluate the analgesic secondary outcomes.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Feyce Peralta, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcomes assessor will be blinded to the assigned randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two group randomized controlled trial

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: January 21, 2020
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2023
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

US (1)