Comparison of PIEB vs CEI for Labor Analgesia

NCT02949271 | Completed Phase 4 Results

• 1 other identifier: Pro00077123
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analgesia. The primary outcome will be the volume of local anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus, labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of successful to unsuccessful attempts, frequency of hypotension, duration of first and second stages of labor and level of patient satisfaction. The investigator plans to enroll 120 nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1% with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be analyzed using Chi-square test or Fisher's exact test as appropriate.

Conditions

Labor Pain

Keywords

epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Volume of Local Anesthetic Received Through Patient Controlled Epidural Analgesia (PCEA) Per Hour

  The volume of local anesthetic that the patient received through activation of the patient-controlled epidural analgesia system per hour.

  duration of labor, up to 24hrs

Secondary Outcomes (10)

• Volume of Local Anesthetic Required Per Hour

  duration of labor, up to 24hrs

• Time to First Patient Controlled Epidural Analgesia (PCEA) Bolus

  duration of labor, up to 24hrs

• Maximum Reported Labor Pain Score

  duration of labor, up to 24hrs

• Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score

  duration of labor, up to 24hrs

• Total Number of Subjects Experiencing Each Mode of Delivery

  duration of labor, up to 24hrs

Study Arms (2)

Programmed Intermittent Epidural Bolus

ACTIVE COMPARATOR

Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.

Other: Programmed Intermittent Epidural Bolus; Drug: Ropivacaine; Drug: Fentanyl

Continuous Epidural Infusion

ACTIVE COMPARATOR

Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.

Other: Continuous Epidural Infusion; Drug: Ropivacaine; Drug: Fentanyl

Interventions

Programmed Intermittent Epidural Bolus OTHER

Programmed Intermittent Epidural Bolus

Continuous Epidural Infusion OTHER

Continuous Epidural Infusion

Ropivacaine DRUG

Continuous Epidural Infusion; Programmed Intermittent Epidural Bolus

Fentanyl DRUG

Continuous Epidural Infusion; Programmed Intermittent Epidural Bolus

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiology (ASA) class 2 and 3 women
• Nulliparous
• Age \> 18 yrs
• gestational age \> 36 weeks
• singleton pregnancies
• vertex pregnancies
• spontaneous labor or scheduled induction of labor
• cervical dilatation 2-5 cm at time of epidural placement
• Pain score \> 5

You may not qualify if:

• BMI \> 50 kg/m2
• history of past or current intravenous drug or chronic opioid abuse
• chronic analgesic use
• allergy or contraindication to any study medications
• any maternal or fetal condition requiring planned assisted stage 2 delivery

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (10)

• Vermelis JM, Wassen MM, Fiddelers AA, Nijhuis JG, Marcus MA. Prevalence and predictors of chronic pain after labor and delivery. Curr Opin Anaesthesiol. 2010 Jun;23(3):295-9. doi: 10.1097/aco.0b013e32833853e8.

  PMID: 20446346 BACKGROUND

• Leighton BL, Halpern SH. The effects of epidural analgesia on labor, maternal, and neonatal outcomes: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S69-77. doi: 10.1067/mob.2002.121813.

  PMID: 12011873 BACKGROUND

• Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. doi: 10.1056/NEJMoa042573.

  PMID: 15716559 BACKGROUND

• Thornton JG, Capogna G. Reducing likelihood of instrumental delivery with epidural anaesthesia. Lancet. 2001 Jul 7;358(9275):2. doi: 10.1016/s0140-6736(00)05295-8. No abstract available.

  PMID: 11454363 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

• 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

• Leone Roberti Maggiore U, Silanos R, Carlevaro S, Gratarola A, Venturini PL, Ferrero S, Pelosi P. Programmed intermittent epidural bolus versus continuous epidural infusion for pain relief during termination of pregnancy: a prospective, double-blind, randomized trial. Int J Obstet Anesth. 2016 Feb;25:37-44. doi: 10.1016/j.ijoa.2015.08.014. Epub 2015 Oct 1.

  PMID: 26431778 BACKGROUND

• George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

  PMID: 23223119 BACKGROUND

• Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.

  PMID: 27100210 BACKGROUND

• McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.

  PMID: 26775896 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Ropivacaine; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ashraf Habib, M.D.
• Organization: Duke University

ashraf.habib@duke.edu

919-681-4544

Study Officials

• Ashraf S Habib, MBBCh

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: November 8, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 11, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Locations

US (1)