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Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105558
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Lynne Erian, The University of Texas Health Science Center, Houston

Brief Summary:
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).

Condition or disease Intervention/treatment Phase
Labor Pain Complications; Cesarean Section Pregnancy Drug: Epidural anesthesia Drug: Combined spinal and epidural anesthesia Phase 4

Detailed Description:

Though it has been said, "once a cesarean, always a cesarean," the current medical stance has changed and now encourages vaginal birth after cesaren (VBAC) in a select population of patients. VBAC has several advantages over a repeat cesarean including decreased recovery period, decreased risk of infection, avoidance of major abdominal surgery, and lessened blood loss. Predictors for success of VBAC include previous spontaneous vaginal birth, singleton pregnancy, and previous low transverse scar for C-section delivery. TOLAC is a reasonable option for select pregnant women and is associated with a 74% likelihood of VBAC. Risk factors for failure of VBAC include labor dystocia, advanced maternal age, maternal obesity, fetal macrosomia, gestational age (GA) >40 weeks, short inter pregnancy interval, and preeclampsia.

While success of VBAC is associated with fewer complications, failure of VBAC may be associated with increased complications. A major concern for VBAC is the possibility for uterine rupture, which may result in hysterectomy and intrapartum fetal hypoxia/death. According to the American College of Obstetricians and Gynecologists (ACOG) guidelines, effective regional analgesia should not be expected to mask the signs and symptoms of uterine rupture, particularly because the most common sign of rupture is fetal heart tracing abnormalities. Adequate pain relief achieved with either CSE or epidurals may even encourage more women to opt for VBAC. The decision to proceed with TOLAC should occur only after appropriate discussion of the risks and benefits has occurred between the patient and her obstetrician and as long as no other contraindications exist. The final decision should be left up to the patient. There is no reliable way to predict risk of uterine rupture, but it may be associated with classical and low vertical uterine scars, induction of labor, and increased number of prior cesarean deliveries and risk may be decreased by previous vaginal birth. Other aspects of VBAC versus repeat cesarean pertaining to the fetus to consider include respiratory function, mother-infant contact, and initiation of breastfeeding, which may be delayed in cesarean deliveries.

There is very little research concerning the effects of CSEs and epidurals on women undergoing TOLAC.There have been multiple studies comparing CSE and epidurals on nulliparous and multiparous women, but none have been done specifically on patients undergoing TOLAC. According to the American Society of Anesthesiologists (ASA) practice guidelines for obstetric anesthesia "nonrandomized comparative studies suggest that epidural analgesia may be used in a trial of labor for previous cesarean delivery patients without adversely affecting the incidence of vaginal delivery. Randomized comparison of epidural versus other anesthetic techniques were not found." They agree that neuraxial techniques improve the likelihood of vaginal delivery for patients attempting VBAC and suggest neuraxial catheter be placed in event of operative delivery. Because no study to date has compared CSEs and epidurals and their effects on the success of VBAC, this study aims to further investigate this arena.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcomes of Epidural Versus Combined Spinal and Epidural (CSE) Anesthetic Technique on the Success of Trial of Labor After Cesarean (TOLAC): A Pilot Study
Study Start Date : April 2014
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : April 13, 2017

Arm Intervention/treatment
Experimental: Epidural anesthesia
Trial of labor after cesarean with an epidural for anesthesia: Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
Drug: Epidural anesthesia

An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.

Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.


Experimental: Combined spinal and epidural anesthesia
Trial of labor after cesarean with a combined spinal and epidural (CSE) for anesthesia: the epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
Drug: Combined spinal and epidural anesthesia

A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.

The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.





Primary Outcome Measures :
  1. Number of Participants With Vaginal Birth After Cesarean (VBAC) [ Time Frame: at the time of delivery ]

Secondary Outcome Measures :
  1. Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) [ Time Frame: baseline ]
    Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.

  2. Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) [ Time Frame: 15 minutes after regional anesthesia ]
    Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.

  3. Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) [ Time Frame: 30 minutes after regional anesthesia ]
    Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.

  4. Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) [ Time Frame: 60 minutes after regional anesthesia ]
    Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.

  5. Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) [ Time Frame: 24 hours after regional anesthesia ]
    Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.

  6. Childbirth Experience as Assessed by a Visual Analogue Scale (VAS) [ Time Frame: 24 hours after regional anesthesia ]
    Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.

  7. Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS) [ Time Frame: 24 hours after regional anesthesia ]
    Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.

  8. Neonatal Outcome as Assessed by (APGAR) Score [ Time Frame: 1 minute after birth ]
    Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.

  9. Neonatal Outcome as Assessed by (APGAR) Score [ Time Frame: 5 minutes after birth ]
    Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.

  10. Time From Regional Anesthesia to Delivery [ Time Frame: from regional anesthesia to delivery (about 86 - 1205 minutes) ]
  11. Time From Second Stage of Labor to Delivery [ Time Frame: from the second stage of labor to delivery (about 6 to 174 minutes) ]
    The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients meeting ACOG guidelines for TOLAC
  • at least one previous elective cesarean delivery
  • <40 weeks gestational age (GA)
  • vertex singleton pregnancy with use of continuous fetal monitoring

Exclusion Criteria:

  • Patient refusal of regional anesthetic or with contraindication for regional anesthesia
  • BMI >40
  • associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105558


Locations
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United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77026
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Opal Raj, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Jennifer Lynne Erian, The University of Texas Health Science Center, Houston:

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Responsible Party: Jennifer Lynne Erian, Resident, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02105558    
Other Study ID Numbers: HSC-MS-14-0023
First Posted: April 7, 2014    Key Record Dates
Results First Posted: July 19, 2018
Last Update Posted: July 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jennifer Lynne Erian, The University of Texas Health Science Center, Houston:
trial of labor after cesarean
vaginal birth after cesarean
epidural vs combined spinal epidural
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Epinephrine
Racepinephrine
Anesthetics
Ropivacaine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics