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This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).
Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).
On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; |
|
| Group 2 | Active Comparator | sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | ropivacaine (15 ml). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia. | The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia. | During surgery: postoperative day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Motor Block | during surgery from induction time to end case time | |
| Time to Onset of First Sensory Block | during surgery | |
| Maximum Verbal Response Score (VRS) With Rest |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to supraclavicular block
Pregnancy
Preexisting neuropathy involving the surgical limb
Routine opioid use
Inability to attain adequate ultrasound images in the supraclavicular area
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Ritchey, MD | Cleveland Clinid | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) |
| FG001 | Control | sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Duration of Analgesia. | The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia. | Posted | Median | Inter-Quartile Range | minute | During surgery: postoperative day 0 |
|
after surgery to hospital discharge
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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 | Group 1 | combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Kumar, MD | University of North Carolina, Department of Anesthesiology, University of North Carolina | (919) 966-5136 | pkumar@aims.unc.edu, |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Mepivacaine |
| Drug |
One syringe will contain mepivacaine (15 ml) |
|
The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain |
| through post operative day 3 |
| Maximum Verbal Response Score (VRS) With Movement | The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst | through post operative day 3 |
| Duration of Analgesia | Time from the complete onset of sensory block until first request for an analgesic | from surgery date to postoperative day 1 |
| Total Opioid Consumption | In morphine equivalent dose | postoperative day 1 to day 3 |
| Group 2 |
sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Time to Complete Motor Block | Posted | Median | Inter-Quartile Range | minutes | during surgery from induction time to end case time |
|
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|
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| Secondary | Time to Onset of First Sensory Block | Posted | Median | Inter-Quartile Range | minutes | during surgery |
|
|
|
|
| Secondary | Maximum Verbal Response Score (VRS) With Rest | The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain | Posted | Median | Inter-Quartile Range | mm | through post operative day 3 |
|
|
|
|
| Secondary | Maximum Verbal Response Score (VRS) With Movement | The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst | Posted | Median | Inter-Quartile Range | mm | through post operative day 3 |
|
|
|
|
| Secondary | Duration of Analgesia | Time from the complete onset of sensory block until first request for an analgesic | Posted | Median | Inter-Quartile Range | hours | from surgery date to postoperative day 1 |
|
|
|
|
| Secondary | Total Opioid Consumption | In morphine equivalent dose | Posted | Median | Inter-Quartile Range | mg | postoperative day 1 to day 3 |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Group 2 | sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml) | 0 | 51 | 0 | 51 | 0 | 51 |
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| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |