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Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline pretreatment, saline admixture |
|
| Lidocaine pretreatment | Active Comparator | Lidocaine pretreatment / saline-propofol admixture |
|
| Lidocaine-Propofol admixture | Active Comparator | saline pretreatment / Lidocaine-propofol admixture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 3.3 mL normal saline |
| |
| Lidocaine / propofol admixture |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Pain Score | 11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain | Immediately after injection of study drug. One time assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Alleviation of Injection Pain | Total subjects within the arm versus those subjects who had no pain with injection (VPS=0) | Immediately after injection of study drug. One time assessment |
| Satisfaction With Anesthetic Technique |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Neal, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benaroya Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21455088 | Derived | Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da. |
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Patients entered were recruited between January 2008 and March 2009. Hospital / ambulatory surgery setting
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | saline pretreatment, saline plus propofol admixture |
| FG001 | Lidocaine / Propofol Admixture Arm | saline pretreatment, lidocaine plus propofol admixture |
| FG002 | Lidocaine Pretreatment Arm | lidocaine pretreatment, saline plus propofol admixture |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | saline pretreatment, saline plus propofol admixture |
| BG001 | Lidocaine / Propofol Admixture Arm | saline pretreatment, lidocaine plus propofol admixture |
| 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 | Verbal Pain Score | 11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain | Posted | Median | Inter-Quartile Range | Units on a scale | Immediately after injection of study drug. One time assessment. |
|
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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 | Control Arm | saline pretreatment, saline plus propofol admixture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph M. Neal, MD | Virginia Mason Medical Center | 206-223-6980 | anejmn@vmmc.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
lidocaine 50 mg plus propofol 50 mg intravenous (iv) |
|
| lidocaine pretreatment | Drug | lidocaine 50 mg iv under tourniquet-control |
|
Were you satisfied with the anesthetic technique? Yes/No
| Prior to discharge. One time assessment |
| BG002 | Lidocaine Pretreatment Arm | lidocaine pretreatment, saline plus propofol admixture |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Complete Alleviation of Injection Pain | Total subjects within the arm versus those subjects who had no pain with injection (VPS=0) | Posted | Number | Participants | Immediately after injection of study drug. One time assessment |
|
|
|
|
| Secondary | Satisfaction With Anesthetic Technique | Were you satisfied with the anesthetic technique? Yes/No | Posted | Number | Participants | Prior to discharge. One time assessment |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Lidocaine / Propofol Admixture Arm | saline pretreatment, lidocaine plus propofol admixture | 0 | 51 | 0 | 51 |
| EG002 | Lidocaine Pretreatment Arm | lidocaine pretreatment, saline plus propofol admixture | 0 | 53 | 0 | 53 |
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| D017670 |
| Sodium Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|