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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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 |
- VAS Pain Scores [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- 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 TJUH. 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 |
Inclusion Criteria:
- speaks English
Exclusion Criteria:
- children,
- neuropathy in operative arm
Contacts and 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 | |
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: | September 25, 2012 |
| 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 May 23, 2013