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

This study has been completed.
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: September 13, 2012
Last updated: October 14, 2015
Last verified: October 2015
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 Intervention
Shoulder Pain Device: interscalene nerve catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Further study details as provided by Thomas Jefferson University:

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

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

  • 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

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

Enrollment: 84
Study Start Date: July 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01696188

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

Responsible Party: Thomas Jefferson University Identifier: NCT01696188     History of Changes
Other Study ID Numbers: 12D.328
Study First Received: September 13, 2012
Results First Received: August 4, 2015
Last Updated: October 14, 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 processed this record on July 21, 2017