Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor

NCT01621230 | Completed Phase 4 Results DMC

• 1 other identifier: STU 042011-045
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengthen the second stage of labor? The secondary research question is: Is there other evidence of motor blockade attributable to bupivacaine during the second stage of labor? The investigators know from prior studies that the length of the second stage in nulliparous women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33% increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores during the second stage as well as the uterine contractility data are not available as these indices of motor blockade have not here-to-fore been studied in this context. Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at term receive continuous epidural infusions with bupivacaine during the first and second stages of labor. Such women will be identified when admitted for scheduled inductions at Parkland. After informed consent is obtained standard management of labor induction will be provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see study procedure below). Both the patient and the caregiver will be blinded as to whether the patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33% increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and given that approximately 1000 women meet the inclusion criteria each year at Parkland, the investigators project that this study could be completed in 12 months.

Conditions

Pregnancy

Keywords

Bupivacaine; Fentanyl; Epidural; Second Stage of Labor; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The Duration of the Second Stage of Labor

  The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone.

  Duration of second stage of labor approximately 30 minutes to 150 minutes

Secondary Outcomes (4)

• Local Anesthetic Motor Blockade Indices During Stage II of Labor

  Duration of second stage of labor approximately 30 minutes to 150 minutes

• Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor

  At the time of Delivery

• Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min

  At the time of Delivery, up to 3 hours

• Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min

  At the time of Delivery, up to 3 hours

Study Arms (2)

Epidural fentanyl

ACTIVE COMPARATOR

A continuous epidural infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 ml/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 mL/hr for pain. Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed.

Drug: Epidural fentanyl

Epidural bupivacaine plus fentanyl

PLACEBO COMPARATOR

A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed .

Drug: Epidural Bupivacaine plus fentanyl

Interventions

Epidural Bupivacaine plus fentanyl DRUG

The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr.

Also known as: Epidural continous infusion of bupivacaine and fentanyl

Epidural bupivacaine plus fentanyl

Epidural fentanyl DRUG

The subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr.

Also known as: Epidural continous infusion of fentanyl

Epidural fentanyl

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Nulliparous women at 37 weeks gestation or greater.
• Scheduled for induction of labor for any indication, to include hypertensive disorders, diabetes, decreased fetal motion, or prolonged pregnancy.
• Single without known malformations.
• Maternal age \> or equal to 16 years.
• ASA classification 1 or 2.

You may not qualify if:

• Women who refuse epidural analgesia.
• Women with contraindications to epidural analgesia, i.e., severe thrombocytopenia.
• Any renal disease with serum creatinine \> 1.0 mg/dL.
• Allergy to bupivacaine or fentanyl.
• Known liver disease such as hepatitis.
• Known contraindications to internal electronic fetal monitoring i.e., active herpes, maternal HIV seropositivity.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Craig MG, Grant EN, Tao W, McIntire DD, Leveno KJ. A randomized control trial of bupivacaine and fentanyl versus fentanyl-only for epidural analgesia during the second stage of labor. Anesthesiology. 2015 Jan;122(1):172-7. doi: 10.1097/ALN.0000000000000454.

  PMID: 25254902 RESULT

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Margaret Craig, MD
• Organization: UTexasSouthwestern

maggieanes@gmail.com

2142638919

Study Officials

• Kenneth Leveno, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Lisa Moseley

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: double-blinded 2 arm

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: June 18, 2012
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (1)