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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-plane group | Experimental | This group will receive an interscalene catheter placed with in-plane approach. |
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| Out-of-plane group | Experimental | This group will receive an interscalene catheter with an out-of-plan approach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interscalene nerve catheter | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Scores | Pain was rated from 0 (no pain) to 10 (worst pain imaginable) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Dislodgements | Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not. | 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21425511 | Background | 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. | |
| 19258990 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | In-plane Group | This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter |
| FG001 | Out-of-plane Group | This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 48 hours |
| Time for Block Placement | Calculate the time to perform the nerve block procedure. | immediately post-procedure |
| 19258989 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | In-plane Group | This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter |
| BG001 | Out-of-plane Group | This group will receive an interscalene catheter with an out-of-plan approach. interscalene nerve catheter |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale Pain Scores | Pain was rated from 0 (no pain) to 10 (worst pain imaginable) | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours |
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| Secondary | Catheter Dislodgements | Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not. | Posted | Number | participants | 24 hours |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | mg IV morphine equivalents | 48 hours |
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| Secondary | Time for Block Placement | Calculate the time to perform the nerve block procedure. | Posted | Mean | 95% Confidence Interval | seconds | immediately post-procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-plane Group | This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter | 0 | 40 | 0 | 40 | ||
| EG001 | Out-of-plane Group | This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter | 0 | 42 | 0 | 42 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Schwenk | Sidney Kimmel Medical College at Thomas Jefferson University | 215-955-6161 | Eric.Schwenk@jefferson.edu |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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