NCT02274467

Brief Summary

Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness and safety. Despite its very high success rate, the epidural technique remains a rather blind technique and failures continue to occur. The correct placement of an epidural catheter, however, remains a clinical problem, since there is no imaging technique that could be used at the bedside to determine the exact positioning of the catheter. The technique of a trans-catheter electric stimulation test (TCEST) has been successfully used to detect the proper epidural catheter location for pediatric, post-operative and laboring obstetric patients. The response to the TCEST with the uniport (single hole) epidural catheters has been well described. There is a growing body of evidence that multiport epidural catheters provide an advantage to uniport catheters, since additional ports likely allow for an enhanced distribution of the local anesthetic solution. This was shown to result in a lower incidence of inadequate analgesia, including unilateral sensory blockade and missed sensory segments. The characteristics of the TCEST response using a multiport catheter remain to be determined. The aim of this study is to compare the response patterns to the TCEST using a single port versus multiport wire reinforced epidural catheters. The hypothesis of this study is that the incidence of a bilateral response to the TCEST will be higher in the multiport catheter as compared to the uniport catheter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

October 9, 2014

Last Update Submit

February 18, 2015

Conditions

Labor Pain

Keywords

Tsui TestLabourEpidural catheter

Outcome Measures

Primary Outcomes (1)

  • Motor response pattern

    Motor response pattern to the electrical stimulation of the epidural catheter, either unilateral or bilateral

    5 minutes

Secondary Outcomes (4)

  • Current (mA)

    5 minutes

  • Sensory level

    20 minutes

  • Epidural block failure

    20 minutes

  • Catheter replacement

    2 hours

Study Arms (2)

Uniport catheter

ACTIVE COMPARATOR

19 gauge uniport epidural catheter

Device: Trans-catheter electric stimulation test

Multiport catheter

ACTIVE COMPARATOR

19 gauge multiorifice epidural catheter

Device: Trans-catheter electric stimulation test

Interventions

Trans-catheter electric stimulation testDEVICE
Also known as: Tsui test
Multiport catheterUniport catheter

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women over 18 years of age requesting an epidural for labor and delivery
  • Able to communicate in English
  • Informed consent

You may not qualify if:

  • Refusal to provide written informed consent
  • Unable to communicate in English
  • Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
  • Abnormal vertebral anatomy, including previous spine surgery and scoliosis
  • Coexisting neurological disorders
  • Implanted electronic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 24, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

CA(1)