N/A
N=100
Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters
Pain, Postoperative · Pain, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02678039 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Intravenous Pain Medication — 63; 66 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluoroscopy (Device); Traditional (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intravenous Pain Medication |
63; 66 | — |
| SECONDARY Incidence of Epidural Catheter Failure |
74; 98 | — |
| SECONDARY Postoperative Pain Intensity Measured by Numeric Scale |
— | — |
| SECONDARY Postoperative Pain Intensity Measured by Numeric Scale |
— | — |
| SECONDARY Postoperative Pain Intensity Measured by Numeric Scale |
— | — |
Summary
This is a prospective, randomized, controlled, and single blinded study. All work performed at Dartmouth-Hitchcock Medical Center, a tertiary care and level one trauma center for the state of New Hampshire with 28 operative suites. 100 patients scheduled to undergo thoracotomies are randomized to receive an epidural placed (for postoperative pain control) using either a traditional approach by feeling the spine for landmarks or using fluoroscopic X-ray guidance. Randomization is blinded to both the anesthesia team caring for the patient in the operating room and to one member of the acute pain team who follows the patient after surgery and is responsible for evaluating post operative pain control (dermatomal distribution of sensory blockade and visual analog scale) and pulmonary function (incentive spirometer use). All patients receive a standardized epidural infusion with local anesthetic and additional pain medications as needed.
Eligibility Criteria
Inclusion Criteria
- Patient scheduled for open thoracotomy procedure
- Patient provides informed consent
Exclusion Criteria
- Age less than 19
- Pregnancy
- Contraindication to an epidural catheter placement bleeding disorder cardiac valve stenosis systemic infection spinal abnormality
- Allergy to local anesthetics or X-ray dye
- Patient refusal to participate
Data sourced from ClinicalTrials.gov (NCT02678039). 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.