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

NCT02105558 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-14-0023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Labor Pain; Complications; Cesarean Section; Pregnancy

Keywords

trial of labor after cesarean; vaginal birth after cesarean; epidural vs combined spinal epidural

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Vaginal Birth After Cesarean (VBAC)

  at the time of delivery

Secondary Outcomes (11)

• Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)

  baseline

• Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)

  15 minutes after regional anesthesia

• Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)

  30 minutes after regional anesthesia

• Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)

  60 minutes after regional anesthesia

• Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)

  24 hours after regional anesthesia

Study Arms (2)

Epidural anesthesia

EXPERIMENTAL

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

Combined spinal and epidural anesthesia

EXPERIMENTAL

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

Interventions

Epidural anesthesia DRUG

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.

Epidural anesthesia

Combined spinal and epidural anesthesia DRUG

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.

Combined spinal and epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Lyndon B. Johnson Hospital

Houston, Texas, 77026, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

lower than expected sample size (the study was powered for 60 but only 46 participants were enrolled)

Results Point of Contact

• Title: Madhumani Rupasinghe, MD
• Organization: The University of Texas Health Science Center at Houston

Madhumani.Rupasinghe@uth.tmc.edu

(713) 500-6200

Study Officials

• Opal Raj, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: July 19, 2018
• Results First Posted: July 19, 2018

Record last verified: 2018-06

Locations

US (1)