Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses

NCT02340806 | Completed Results

• 1 other identifier: STU00100819
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.

Conditions

Labor Pain; Obstetric Pain

Keywords

epidural bolus; pain management; labor analgesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Breakthrough Pain.

  Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.

  epidural placement to delivery, up to 36 hours.

Secondary Outcomes (5)

• Total Bupivacaine Consumption Per Hour of Labor Analgesia

  epidural placement to delivery, up to 36 hours.

• Total Number of Requested PCEA Boluses

  epidural placement to delivery, up to 36 hours.

• Total Number of Delivered PCEA Boluses

  epidural placement to delivery, up to 36 hours.

• Ratio of Total Number of PCEA Boluses Requested and Delivered

  epidural placement to delivery, up to 36 hours.

• Satisfaction Scores

  up to 24 hours after delivery

Other Outcomes (5)

• Time to Provider Administered Supplemental Boluses

  epidural to first request of redose up to 10 hours

• Mean Pain Score

  epidural placement to delivery, up to 36 hours.

• Stage of Labor at Re-dose Request

  Through 2 stages of labor up to 24 hours

Study Arms (2)

High rate bolus (CADD-Solis pump)

EXPERIMENTAL

Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 300 mL/h in the high-rate bolus group.

Device: CADD-Solis pump (Smiths Medical)

Low rate bolus (CADD-Solis pump)

EXPERIMENTAL

Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump. The bolus rate will be 100 mL/h in the low-rate bolus group.

Device: CADD-Solis pump (Smiths Medical)

Interventions

CADD-Solis pump (Smiths Medical) DEVICE

The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).

High rate bolus (CADD-Solis pump); Low rate bolus (CADD-Solis pump)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Term, nulliparous, English-speaking patients with singleton vertex pregnancies, who were 18 years or older, who presented to the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital in spontaneous labor or for induction of labor were eligible to participate in the study

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• 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

• Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.

  PMID: 21788309 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

• Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.

  PMID: 21430035 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

Limiting our study subjects to nulliparous patients in early labor could have led to a cohort that was more prone to sysfunctional labor and these results could be different in multiparous women with shorter labors.

Results Point of Contact

• Title: Elizabeth Lange, MD
• Organization: Northwestern University

elizabeth.lange@northwestern.edu

312-472-3585

Study Officials

• Elizabeth Lange, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 26, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)