Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor (BUP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Margaret Craig, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01621230
First received: February 6, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy
Drug: epidural 0.125% bupivacaine with fentanyl 2 mcg/cc infusion
Drug: fentanyl 10 mcg/cc epidural infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Trial of the Effects of Bupivacaine Induced Motor Blockade on the Second Stage of Labor

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Length of the Second Stage of Labor [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The primary outcome is to evaluate the effects of epidural bupivacaine on the duration of the second stage of labor (measured as minutes a parturient spends in Stage II). The investigators propose to compare the length of the second stage in nulliparous women given a standard bupivacaine and fentanyl epidural infusion during the second stage to women given an identical study solution containing only fentanyl. The primary outcome of interest is the length of the second stage of labor which will be used as an indirect index of motor blockade due to bupivacaine.


Secondary Outcome Measures:
  • Local Anesthetic Motor Blockade Indices during Stage II of Labor [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Secondary outcomes of interest include uterine contractility measured via standard intrauterine contraction pressure transducers (measuring area under the curve in MDU's) which are normally used for labor surveillance as well as Bromage and Breen scores (measured on a 6-point standardized scale) that estimate motor blockade. This latter scoring system is based upon the laboring womans' ability to move her lower extremities.


Estimated Enrollment: 310
Study Start Date: September 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group II
Group II will receive a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) will receive meperidine 25 mg iv for breakthrough pain as needed.
Drug: fentanyl 10 mcg/cc epidural infusion

Randomization will occur when the woman reaches 8 cm cervical dilation. Group II will receive a 100mL cassette of fentanyl 10mcg/mL (to be infused at 10mL/hr). Group I will receive a 100mL epidural cassette of 0.125% bupivacaine with fentanyl 2mcg/mL to be infused at 10mL/hr.Both groups will have the same rate of epidural infusion such that the patient, nurse, obstetrician, and anesthesia providers will be blinded to the randomized treatment group.

The patient may request a 5mL bolus from the epidural infusion every 30 minutes if pain relief is inadequate. The study regimen will continue until spontaneous delivery of the infant or until which time operative vaginal delivery or cesarean delivery is planned.

Placebo Comparator: Group I
Group I will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I will be allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.
Drug: epidural 0.125% bupivacaine with fentanyl 2 mcg/cc infusion

Randomization will occur when the woman reaches 8 cm cervical dilation. Group II will receive a 100mL cassette of fentanyl 10mcg/mL (to be infused at 10mL/hr). Group I will receive a 100mL epidural cassette of 0.125% bupivacaine with fentanyl 2mcg/mL to be infused at 10mL/hr. Both groups will have the same rate of epidural infusion such that the patient, nurse, obstetrician, and anesthesia providers will be blinded to the randomized treatment group.

The patient may request a 5mL bolus from the epidural infusion every 30 minutes if pain relief is inadequate. The study regimen will continue until spontaneous delivery of the infant or until which time operative vaginal delivery or cesarean delivery is planned.


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  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621230

Contacts
Contact: Margaret G. Craig, MD (214) 590-7252 Margaret.Craig@utsouthwestern.edu
Contact: Dawn Wilson (214) 648-2316 Dawn.Wilson@utsouthwestern.edu

Locations
United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Margaret G Craig, MD    214-590-7252    Margaret.Craig@utsouthwestern.edu   
Contact: Lisa Moseley    (214) 648-2316    Lisa.Moseley@utsouthwestern.edu   
Sub-Investigator: Weike Tao, MD         
Sub-Investigator: Donald McIntire, Ph.D         
Sub-Investigator: James Alexander, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Chair: Kenneth Leveno, MD UT Southwestern Medical Center
Study Director: Lisa Moseley UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Margaret Craig, Primary Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01621230     History of Changes
Other Study ID Numbers: 052009-049
Study First Received: February 6, 2012
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Bupivacaine
Fentanyl
Epidural
Second Stage of Labor
Randomized Controlled Trial

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014