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

NCT02105558 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-07-19

Study results available
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Summary

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

Conditions

  • Labor Pain
  • Complications; Cesarean Section
  • Pregnancy

Interventions

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.

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Opal Raj, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-04-13
Completion
2017-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105558 on ClinicalTrials.gov