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The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr |
|
| Placebo | Active Comparator | Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | 6 hours post-surgery |
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | 12 hours post-surgery |
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | 18 hours post-surgery |
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | 24 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Karlnoski, PhD | Florida Gulf-to-Bay Anesthesiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr Lidocaine |
| FG001 | Placebo | Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Patients received 2mg/kg/hr of lidocaine intraoperatively from the time of induction until the time of emergence. |
| BG001 | Placebo Arm | Patients received 2mg/kg/hr of placebo (saline) intraoperatively from the time of induction until the time of emergence. |
| 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 | Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | Posted | Median | Full Range | units on a scale | 6 hours post-surgery |
|
Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
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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 | Lidocaine | Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr Lidocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment | post-operation lightheadedness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrico Camporesi MD | TeamHealth Anesthesia | 813-844-7170 | ecampore@health.usf.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | Posted | Median | Full Range | units on a scale | 12 hours post-surgery |
|
|
|
| Primary | Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | Posted | Median | Full Range | units on a scale | 18 hours post-surgery |
|
|
|
| Primary | Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | Posted | Median | Full Range | units on a scale | 24 hours post-surgery |
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Placebo | Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr Placebo | 0 | 10 | 5 | 10 |
| Metallic Taste in Mouth | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Significant Blood Pressure Changes | Blood and lymphatic system disorders | Systematic Assessment | Postoperative blood pressure change that is greater than 20% from the baseline blood pressure measured preoperatively. |
|
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| Aniline Compounds |
| D000588 | Amines |
| Moving VAS |
|
| Moving VAS |
|
| Moving VAS |
|