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Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

NCT02678039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-09-12

Study results available
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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.

Conditions

  • Pain, Postoperative
  • Pain, Chronic

Interventions

DEVICE

Fluoroscopy

Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr

PROCEDURE

Traditional

An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-01-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678039 on ClinicalTrials.gov