Analgesia, Epidural
Conditions
Brief summary
This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.
Detailed description
In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.
Interventions
PROCEDUREThoracic Epidural Placement
Thoracic Epidural Placement
DRUGBupivacaine 0.05%
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
DRUGHydromorphone 0.01mg/mL
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Sponsors
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiology Classification I-IV * thoracic surgery * abdominal surgery
Exclusion criteria
* contraindications to epidural catheter * pregnancy * coagulopathy * infection (localized) * allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to epidural space identification | Estimated 10 minutes | Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Needle passes | Estimated 10 minutes | Attempt to place needle into the interlaminar foramina. Needle tip movements toward midline and cephalad were counted as s single pass. Additional passes were counted when the needle was returned to a plane parallel to the skin. |
| Needle skin punctures | Estimated 10 minutes | Complete needle withdrawal from the skin and re-insertion at new location |
| Pain Score | Through study completion, estimated 4 hours | Numeric rating scale pain score on recovery room arrival, prior to IV analgesics. |
| Working epidural | Through study completion, estimated 4 hours | Loss of temperature discrimination to ice and pain score \<= 5. |
Countries
United States
Outcome results
None listed