PIEB vs CEI for Labor Analgesia: An MLAC Study

NCT02573597 | Terminated Phase 4 Results DMC

• 1 other identifier: 34734
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion

  The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.

  From initial epidural bolus to delivery (up to approximately 16 hours)

Secondary Outcomes (7)

• Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)

  From initial epidural bolus to delivery (up to 16 hours following initial bolus)

• Numerical Verbal Pain Scores

  Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)

• Patient Satisfaction With Labor Analgesia

  Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)

• Labor Outcome (Spontaneous, Assisted, Cesarean)

  At the time of delivery

• Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension

  From initial epidural bolus to delivery (up to 16 hours following initial bolus)

Other Outcomes (6)

• Maternal Pruritis

  From initial epidural bolus to delivery (up to 16 hours following initial bolus)

• Motor Weakness

  From initial epidural bolus to delivery (up to 16 hours following initial bolus)

• Number and Total Dose of Clinician Rescue Boluses

  From initial epidural bolus to approximately 6-12 hours following delivery

Study Arms (4)

Part A Group 1

ACTIVE COMPARATOR

CEI bupivacaine and CEI sufentanil

Drug: Bupivacaine; Drug: Sufentanil

Part A Group 2

ACTIVE COMPARATOR

PIEB bupivacaine and PIEB sufentanil

Drug: Bupivacaine; Drug: Sufentanil

Part B Group 3

ACTIVE COMPARATOR

CEI bupivacaine and PIEB sufentanil

Drug: Bupivacaine; Drug: Sufentanil

Part B Group 4

ACTIVE COMPARATOR

PIEB bupivacaine and CEI sufentanil

Drug: Bupivacaine; Drug: Sufentanil

Interventions

Bupivacaine DRUG

Continuous or bolus administration

Also known as: marcaine

Part A Group 1; Part A Group 2; Part B Group 3; Part B Group 4

Sufentanil DRUG

Continuous or bolus administration

Also known as: sufenta

Part A Group 1; Part A Group 2; Part B Group 3; Part B Group 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I \& II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix \<5 cm (if known)), Pain (VPS) \> 3, 18-45 years of age

You may not qualify if:

• \<37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol

Sponsors & Collaborators

• Stanford University: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (2)

• 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

• Ginosar Y, Columb MO, Cohen SE, Mirikatani E, Tingle MS, Ratner EF, Angst MS, Riley ET. The site of action of epidural fentanyl infusions in the presence of local anesthetics: a minimum local analgesic concentration infusion study in nulliparous labor. Anesth Analg. 2003 Nov;97(5):1439-1445. doi: 10.1213/01.ANE.0000081792.84877.A2.

  PMID: 14570662 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Sufentanil

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study did not meet its planned enrollment and did not achieve power for the intended analysis.

Results Point of Contact

• Title: Dr. Brendan Carvalho
• Organization: Stanford University School of Medicine

bcarvalho@stanford.edu

(650) 861-8607

Study Officials

• Brendan Carvalho, MBBCh, MDCH

  Stanford 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: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Locations

US (1)