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| Name | Class |
|---|---|
| Beaumont Foundation of America | OTHER |
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Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.
Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Initial Bolus 5 ml Ropivacaine |
|
| B | Active Comparator | Initial Bolus 10 ml Ropivacaine |
|
| C | Active Comparator | Initial Bolus 20 ml Ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Initial Bolus 5 ml Ropivacaine via interscalene injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measurements Via Numeric Pain Rating Scales (NRS) | Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable) | Discharge, 24 h, 48h, 12 weeks |
| Change in Diaphragmatic Displacement From Baseline to Post-surgery | Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit. | Baseline, Post anesthesia care unit (PACU) - within 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful" | Participants were asked to rate the helpfulness of their infusion:
| at 24 and 48 hours after discharge from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Hartrick, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| William Beaumont Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22443231 | Result | Hartrick CT, Tang YS, Siwek D, Murray R, Hunstad D, Smith G. The effect of initial local anesthetic dose with continuous interscalene analgesia on postoperative pain and diaphragmatic function in patients undergoing arthroscopic shoulder surgery: a double-blind, randomized controlled trial. BMC Anesthesiol. 2012 Mar 23;12:6. doi: 10.1186/1471-2253-12-6. |
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Subjects were screened per protocol, those that met all inclusion criteria and did not meet any exclusion criteria were randomized per protocol.
Patients were identified from the surgical schedule. Subjects consented using the most current IRB-approved consent form. Informed consent were administered in the pre-operative suites prior to receiving any treatment.
Recruitment started after approval was obtained from the IRB. Recruitment period was Jan 2009 to Dec 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine 5 mL | Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| FG001 | Ropivacaine 10 mL | Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| FG002 | Ropivacaine 20 mL | Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine 5 mL | Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Measurements Via Numeric Pain Rating Scales (NRS) | Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable) | Posted | Mean | 95% Confidence Interval | units on a scale | Discharge, 24 h, 48h, 12 weeks |
|
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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 | Ropivacaine 5 mL | Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig T. Hartrick, MD | William Beaumont Hospital | 248-964-3440 | chartrick@beaumont.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine |
| Drug |
Initial Bolus 10 ml Ropivacaine via interscalene injection |
|
| Ropivacaine | Drug | Initial Bolus 20 ml Ropivacaine via interscalene injection |
|
| Functional Outcome - Simple Shoulder Test (SST) |
At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed. |
| Baseline, 12 weeks |
| Troy |
| Michigan |
| 48085 |
| United States |
| BG001 |
| Ropivacaine 10 mL |
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| BG002 | Ropivacaine 20 mL | Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Ropivacaine 20 mL | Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. |
|
|
| Primary | Change in Diaphragmatic Displacement From Baseline to Post-surgery | Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit. | Posted | Mean | 95% Confidence Interval | percent change | Baseline, Post anesthesia care unit (PACU) - within 8 hours |
|
|
|
| Secondary | Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful" | Participants were asked to rate the helpfulness of their infusion:
| Posted | Number | percentage of participants | at 24 and 48 hours after discharge from the hospital |
|
|
|
| Secondary | Functional Outcome - Simple Shoulder Test (SST) | At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 12 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Ropivacaine 10 mL | Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. | 0 | 12 | 0 | 12 |
| EG002 | Ropivacaine 20 mL | Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. | 0 | 12 | 0 | 12 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
|
|