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Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.
Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% bupivacaine | Active Comparator | interscalene nerve block with 0.25% bupivacaine |
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| 0.125% bupivacaine | Active Comparator | interscalene nerve block with 0.125% bupivacaine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interscalene nerve block with 0.25% bupivacaine | Drug | interscalene nerve block performed with 20 ml of 0.25% bupivacaine |
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| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Lung Function | Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery. | At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery. | At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Thackeray, MD, MPH | University of Utah | Principal Investigator |
| Jeffrey Swenson, MD | University of Utah | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedics Center | Salt Lake City | Utah | 84108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.25% Bupivacaine | interscalene nerve block with 0.25% bupivacaine |
| FG001 | 0.125% Bupivacaine | interscalene nerve block with 0.125% bupivacaine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| interscalene block with 0.125% bupivacaine | Drug | interscalene block with 20 ml of 0.125% bupivacaine |
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| Satisfaction With Pain Control | A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control. | Within 30 days |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.25% Bupivacaine | interscalene nerve block with 0.25% bupivacaine |
| BG001 | 0.125% Bupivacaine | interscalene nerve block with 0.125% bupivacaine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | Abnormal Lung Function | Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery. | Power analysis was performed and a drop-out rate of 10% was anticipated. | Posted | Number | participants w/ abnormal diaphragm fxn | At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery |
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| Secondary | Pain Relief | Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery. | Same as other outcome measures. | Posted | Mean | Standard Deviation | Visual Analogue Scale for pain | At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery |
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| Secondary | Satisfaction With Pain Control | A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control. | Same as other outcome measures | Posted | Mean | Standard Deviation | Likert Satisfaction Scale | Within 30 days |
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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 | 0.25% Bupivacaine | interscalene nerve block with 0.25% bupivacaine | 0 | 14 | 0 | 14 | ||
| EG001 | 0.125% Bupivacaine | interscalene nerve block with 0.125% bupivacaine | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Thackeray | University of Utah Department of Anesthesiology | (801) 581-6393 | elizabeth.thackeray@hsc.utah.edu |
| ID | Term |
|---|---|
| D012133 | Respiratory Paralysis |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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