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Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

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ClinicalTrials.gov Identifier: NCT02678039
Recruitment Status : Completed
First Posted : February 9, 2016
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Chronic Device: Fluoroscopy Procedure: Traditional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters
Study Start Date : August 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Fluoroscopy

Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the spinal epidural space at the desired location.

Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.

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

Active Comparator: Traditional

The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection.

Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control.

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.
Other Name: Loss of resistance




Primary Outcome Measures :
  1. Intravenous Pain Medication [ Time Frame: 24 hours after surgery ]
    Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.


Secondary Outcome Measures :
  1. Incidence of Epidural Catheter Failure [ Time Frame: 24 hours after surgery ]
    Percent of epidural catheters that were correctly placed (percentage of catheters).

  2. Postoperative Pain Intensity Measured by Numeric Scale [ Time Frame: Measured at 24 hours after surgery ]
    Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

  3. Postoperative Pain Intensity Measured by Numeric Scale [ Time Frame: Measured at 48 hours after surgery ]
    Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

  4. Postoperative Pain Intensity Measured by Numeric Scale [ Time Frame: 3 months after surgery during follow up office visit with surgeon ]
    Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678039


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02678039    
Other Study ID Numbers: CPHS#23226
First Posted: February 9, 2016    Key Record Dates
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Chronic Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations