Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

NCT02678039 | Completed Results

• 1 other identifier: CPHS#23226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Intravenous Pain Medication

  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.

  24 hours after surgery

Secondary Outcomes (4)

• Incidence of Epidural Catheter Failure

  24 hours after surgery

• Postoperative Pain Intensity Measured by Numeric Scale

  Measured at 24 hours after surgery

• Postoperative Pain Intensity Measured by Numeric Scale

  Measured at 48 hours after surgery

• Postoperative Pain Intensity Measured by Numeric Scale

  3 months after surgery during follow up office visit with surgeon

Study Arms (2)

Fluoroscopy

EXPERIMENTAL

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

Traditional

ACTIVE COMPARATOR

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

Interventions

Fluoroscopy DEVICE

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

Fluoroscopy

Traditional PROCEDURE

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.

Also known as: Loss of resistance

Traditional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for open thoracotomy procedure
• Patient provides informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.

  PMID: 27922948 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Mark P. Yeager, MD
• Organization: Dartmouth-Hitchcock

mark.p.yeager@hitchcock.org

603-650-5922

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 9, 2016
• Study Start: August 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 12, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)