A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01696188
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This is a randomized, double-blinded, prospective study designed to compare two approaches (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing an interscalene nerve block and catheter for pain control after open shoulder surgery. Both approaches have been used successfully but neither has been proven to be superior. Our endpoints are pain scores, time for block placement, and catheter dislodgements. We hypothesized that patients with the out-of-plane approach would have decreased pain and fewer catheter dislodgements.

Condition or disease Intervention/treatment Phase
Shoulder Pain Device: interscalene nerve catheter Not Applicable

Detailed Description:

Interscalene nerve block is an effective method of analgesia for surgery of the upper extremity. Perineural interscalene catheters offer the advantage of extended pain relief up to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to compare two approaches (posterior and anterolateral) to interscalene continuous nerve catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction internal fixation). Specifically, the objectives of this study are to compare measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral approach will produce lower pain scores, less opioid consumption, and fewer catheter dislodgements.

All patients undergoing open shoulder surgery will be recruited and enrollment in the study will not deviate from the current standard of care at Thomas Jefferson University Hospital. All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional anesthesia. Patient medical history will be obtained and blocks will be placed per usual protocol. Block efficacy will be assessed by physical exam immediately after placement by the anesthesiologist and another member of the research team. Operative details, including medications given, will be recorded.

Patient pain scores and medications given in the PACU will be recorded. Supplementary analgesics will be available. Pain scores, medications given, and sensory examinations will be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the study and at several interims before that.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: In-plane group
This group will receive an interscalene catheter placed with in-plane approach.
Device: interscalene nerve catheter
Other Name: Peripheral nerve catheter kit, B Braun (Bethlehem, PA)
Experimental: Out-of-plane group
This group will receive an interscalene catheter with an out-of-plan approach.
Device: interscalene nerve catheter
Other Name: Peripheral nerve catheter kit, B Braun (Bethlehem, PA)

Primary Outcome Measures :
  1. Visual Analog Scale Pain Scores [ Time Frame: 24 hours ]
    Pain was rated from 0 (no pain) to 10 (worst pain imaginable)

Secondary Outcome Measures :
  1. Catheter Dislodgements [ Time Frame: 24 hours ]
    Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.

  2. Opioid Consumption [ Time Frame: 48 hours ]
    Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV

  3. Time for Block Placement [ Time Frame: immediately post-procedure ]
    Calculate the time to perform the nerve block procedure.

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

Inclusion Criteria:

  • speaks English

Exclusion Criteria:

  • children,
  • neuropathy in operative arm

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 identifier (NCT number): NCT01696188

United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University

Responsible Party: Thomas Jefferson University Identifier: NCT01696188     History of Changes
Other Study ID Numbers: 12D.328
First Posted: September 28, 2012    Key Record Dates
Results First Posted: November 16, 2015
Last Update Posted: November 16, 2015
Last Verified: October 2015

Keywords provided by Thomas Jefferson University:
nerve block
nerve catheter
anterolateral approach
posterior approach
shoulder surgery

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms