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

• 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: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Jennifer Lynne Erian, The University of Texas Health Science Center, Houston

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Texas

Lyndon B. Johnson Hospital

Houston, Texas, United States, 77026

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

• 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:

Study Protocol and Statistical Analysis Plan  [PDF] March 24, 2014

More Information

• 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
• 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

• 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:

Labor Pain; Pain; Neurologic Manifestations; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs