Phase 4
N=100
Loss of Resistance, w/wo Stimulation, For Epidural Placement
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03087604 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Success Rate of Placement of a Thoracic Epidural — 41; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Thoracic epidural block (Procedure); Electrical Nerve stimulation (Procedure); Solution For Thoracic epidural block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Placement of a Thoracic Epidural |
41; 45 | — |
| SECONDARY Time Required to Place the Epidural Catheter |
33.9; 24.0 | — |
| SECONDARY Number of Thoracic Spine Levels Attempted |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Adults undergoing intra-thoracic or intra-abdominal procedures that normally would receive thoracic epidurals for post-operative analgesia will be eligible.
Exclusion Criteria
- Subjects with contraindications to regional anesthesia:
- history of allergy to amide local anesthetics
- presence of a progressive neurological deficit
- patients that are on anticoagulant medications that prohibit placement of an epidural
- Systemic infection
- Infection at the site of placement
Data sourced from ClinicalTrials.gov (NCT03087604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.