Shoulder Pain
Conditions
Keywords
Interscalene, nerve block, nerve catheter, in-plane, out-of-plane, anterolateral approach, posterior approach, shoulder surgery
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.
Interventions
DEVICEinterscalene nerve catheter
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* speaks English
Exclusion criteria
* children, * neuropathy in operative arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Scores | 24 hours | Pain was rated from 0 (no pain) to 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Dislodgements | 24 hours | Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not. |
| Opioid Consumption | 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 | immediately post-procedure | Calculate the time to perform the nerve block procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-plane Group This group will receive an interscalene catheter placed with in-plane approach.
interscalene nerve catheter | 40 |
| Out-of-plane Group This group will receive an interscalene catheter with an out-of-plan approach.
interscalene nerve catheter | 42 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | In-plane Group | Out-of-plane Group | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 10.7 | 63.8 years STANDARD_DEVIATION 12 | 65.2 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 40 participants | 42 participants | 82 participants |
| Sex: Female, Male Female | 25 Participants | 17 Participants | 42 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Visual Analog Scale Pain Scores
Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In-plane Group | Visual Analog Scale Pain Scores | 1.3 units on a scale |
| Out-of-plane Group | Visual Analog Scale Pain Scores | 1.5 units on a scale |
Secondary
Catheter Dislodgements
Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-plane Group | Catheter Dislodgements | 4 participants |
| Out-of-plane Group | Catheter Dislodgements | 1 participants |
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
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In-plane Group | Opioid Consumption | 25.0 mg IV morphine equivalents |
| Out-of-plane Group | Opioid Consumption | 35.3 mg IV morphine equivalents |
Secondary
Time for Block Placement
Calculate the time to perform the nerve block procedure.
Time frame: immediately post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| In-plane Group | Time for Block Placement | 296 seconds |
| Out-of-plane Group | Time for Block Placement | 257 seconds |