A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interscalene nerve catheter
Sponsored by

About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Interscalene, nerve block, nerve catheter, in-plane, out-of-plane, anterolateral approach, posterior approach, shoulder surgery
Eligibility Criteria
Inclusion Criteria:
- speaks English
Exclusion Criteria:
- children,
- neuropathy in operative arm
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
In-plane group
Out-of-plane group
Arm Description
This group will receive an interscalene catheter placed with in-plane approach.
This group will receive an interscalene catheter with an out-of-plan approach.
Outcomes
Primary Outcome Measures
Visual Analog Scale Pain Scores
Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
Secondary Outcome Measures
Catheter Dislodgements
Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
Opioid Consumption
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
Calculate the time to perform the nerve block procedure.
Full Information
NCT ID
NCT01696188
First Posted
September 13, 2012
Last Updated
October 14, 2015
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT01696188
Brief Title
A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.
Official Title
Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Interscalene, nerve block, nerve catheter, in-plane, out-of-plane, anterolateral approach, posterior approach, shoulder surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-plane group
Arm Type
Experimental
Arm Description
This group will receive an interscalene catheter placed with in-plane approach.
Arm Title
Out-of-plane group
Arm Type
Experimental
Arm Description
This group will receive an interscalene catheter with an out-of-plan approach.
Intervention Type
Device
Intervention Name(s)
interscalene nerve catheter
Other Intervention Name(s)
Peripheral nerve catheter kit, B Braun (Bethlehem, PA)
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Scores
Description
Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Catheter Dislodgements
Description
Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
Time Frame
24 hours
Title
Opioid Consumption
Description
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 Frame
48 hours
Title
Time for Block Placement
Description
Calculate the time to perform the nerve block procedure.
Time Frame
immediately post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
speaks English
Exclusion Criteria:
children,
neuropathy in operative arm
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21425511
Citation
Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. doi: 10.1097/aap.0b013e31820d5ee6.
Results Reference
background
PubMed Identifier
19258990
Citation
Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53.
Results Reference
background
PubMed Identifier
19258989
Citation
Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7.
Results Reference
background
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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.
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