Clinical trial NCT03087604: Loss of Resistance, w/wo Stimulation, For Epidural Placement
Official title: Loss of Resistance With Nerve Stimulation Versus Loss of Resistance Alone; Effect on Success of Thoracic Epidural Placement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: epidural catheter placement
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: All subjects will receive a thoracic epidural catheter placement at the level appropriate for their surgery and will be randomized to either have the epidural placed with a loss of resistance technique alone or loss of resistance technique with confirmation by nerve stimulation. In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. Nerve stimulation will be started at a pulse width of 0.3 ms and a frequency of 1 Hz and a current of 0.2mA.

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

Primary outcomes:
measure: Success Rate of Placement of a Thoracic Epidural
timeFrame: 15 minutes after administration of a test dose of lidocaine
Secondary outcomes:
measure: Time Required to Place the Epidural Catheter
timeFrame: From the initiation of procedure to end of procedure
measure: Number of Thoracic Spine Levels Attempted
timeFrame: Thirty minutes after start of procedure.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: WakeForestUBMC
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Sean Dobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobson SW, Weller RS, Edwards C, Turner JD, Jaffe JD, Reynolds JW, Henshaw DS. A randomized comparison of loss of resistance versus loss of resistance plus electrical stimulation: effect on success of thoracic epidural placement. BMC Anesthesiol. 2022 Feb 9;22(1):43. doi: 10.1186/s12871-022-01584-x.