Last reviewed · How we verify

NCT03087604

Loss of Resistance, w/wo Stimulation, For Epidural Placement

Completed Phase 4 Results posted Last updated 17 June 2020
What this trial tests

Phase 4 trial testing Thoracic epidural block in Anesthesia in 100 participants. Completed in 11 October 2017.

Timeline
17 March 2017
Primary endpoint
11 October 2017
11 October 2017

Quick facts

Lead sponsorWake Forest University Health Sciences
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment100
Start date17 March 2017
Primary completion11 October 2017
Estimated completion11 October 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 90, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Success Rate of Placement of a Thoracic Epidural Primary · 15 minutes after administration of a test dose of lidocaine

will be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful.

GroupValue95% CI
Traditional Technique Group41
Electric Stimulation Group45
Time Required to Place the Epidural Catheter Secondary · From the initiation of procedure to end of procedure

The time required to place the epidural catheter will be recorded

GroupValue95% CI
Traditional Technique Group33.9± 12.8
Electric Stimulation Group24.0± 8.0

Sponsor's own description

The purpose of this randomized, observer-blinded, investigative trial is to determine if the use of electrical stimulation, compared to the traditional loss of resistance technique alone, improves the success rate of epidural catheter placement at an academic teaching institution.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A randomized comparison of loss of resistance versus loss of resistance plus electrical stimulation: effect on success of thoracic epidural placement.
    Dobson SW, Weller RS, Edwards C, Turner JD, et al · · 2022 · cited 5× · PMID 35139802 · DOI 10.1186/s12871-022-01584-x
  2. A Randomized Comparison of Loss of Resistance Versus Loss of Resistance Plus Electrical Stimulation: Effect On Success of Thoracic Epidural Placement
    Dobson SW, Weller RS, Edwards C, Turner JD, et al · · 2021 · DOI 10.21203/rs.3.rs-544222/v1

Verify or expand the search:

Other trials of Thoracic epidural block

Trials testing the same drug.

Other recruiting trials for Anesthesia

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03087604.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing