PIEB vs CEI for Labor Analgesia: An MLAC Study

Pregnancy Clinical Trial

Official title:

Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02573597
• Other study ID #: 34734
• Status: Terminated
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: May 22, 2018

Study information

• Verified date: September 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.

Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.

Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.

Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.

DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• <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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Bupivacaine
Continuous or bolus administration
• Sufentanil
Continuous or bolus administration

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United States, 

References & 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. Review. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Pruritis	scale from from 0-10	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Other	Motor Weakness	Straight leg lift, yes/no	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Other	Number and Total Dose of Clinician Rescue Boluses		From initial epidural bolus to approximately 6-12 hours following delivery
Other	Total CEI and PIEB Local Anesthetic and Opioid Use		From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Other	Requests to Turn Epidural Down or Stop Infusion.	yes/no	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Other	Duration of Epidural Analgesia		From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Primary	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	Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)	The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups.	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Secondary	Numerical Verbal Pain Scores	The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups.	Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)
Secondary	Patient Satisfaction With Labor Analgesia	0-100% (0 means least satisfaction and 100 means most satisfaction)	Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)
Secondary	Labor Outcome (Spontaneous, Assisted, Cesarean)	Labor outcome in patients who have success or failure outcome were compared between groups.	At the time of delivery
Secondary	Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension	Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported.	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Secondary	Number of Participants With Maternal Nausea/Vomiting	yes/no.	From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Secondary	Protocol Success or Failure	Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -> 0.01% w/v reduction in subsequent participant's local anesthetic.; Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation ->0.01% w/v increase in subsequent LA infusion.	From initial epidural bolus to delivery (up to 16 hours following initial bolus)