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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01696188
First received: September 13, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:
  • VAS Pain Scores [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Catheter dislodgements [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Inspect the peripheral nerve catheters at 48 hours postoperatively and assess for being in-place or not.

  • opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Calculate the total amount of opioid consumed in the first 48 hours after surgery.

  • time for block placement [ Time Frame: immediately post-procedure ] [ Designated as safety issue: No ]
    Calculate the time to perform the nerve block procedure.


Estimated Enrollment: 110
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01696188

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kishor Gandhi, MD, MPH    215-955-6161    kishor.gandhi@jefferson.edu   
Contact: Eric S Schwenk, MD    215-955-6161    eric.schwenk@jefferson.edu   
Principal Investigator: Kishor Gandhi, MD, MPH         
Sponsors and Collaborators
Thomas Jefferson University
  More Information

Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01696188     History of Changes
Other Study ID Numbers: 12D.328
Study First Received: September 13, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Interscalene
nerve block
nerve catheter
in-plane
out-of-plane
anterolateral approach
posterior approach
shoulder surgery

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014