Pain
Conditions
Keywords
propofol, lidocaine, injection pain
Brief summary
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.
Interventions
DRUGSaline
3.3 mL normal saline
DRUGLidocaine / propofol admixture
lidocaine 50 mg plus propofol 50 mg intravenous (iv)
DRUGlidocaine pretreatment
lidocaine 50 mg iv under tourniquet-control
Sponsors
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* weight \>40kg, \<100kg * ambulatory surgery
Exclusion criteria
* allergy to propofol or lidocaine * taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Score | Immediately after injection of study drug. One time assessment. | 11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Alleviation of Injection Pain | Immediately after injection of study drug. One time assessment | Total subjects within the arm versus those subjects who had no pain with injection (VPS=0) |
| Satisfaction With Anesthetic Technique | Prior to discharge. One time assessment | Were you satisfied with the anesthetic technique? Yes/No |
Countries
United States
Participant flow
Recruitment details
Patients entered were recruited between January 2008 and March 2009. Hospital / ambulatory surgery setting
Participants by arm
| Arm | Count |
|---|---|
| Control Arm saline pretreatment, saline plus propofol admixture | 52 |
| Lidocaine / Propofol Admixture Arm saline pretreatment, lidocaine plus propofol admixture | 51 |
| Lidocaine Pretreatment Arm lidocaine pretreatment, saline plus propofol admixture | 53 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Lidocaine / Propofol Admixture Arm | Lidocaine Pretreatment Arm | Control Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 15 Participants | 10 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 38 Participants | 42 Participants | 121 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 14 | 52 years STANDARD_DEVIATION 17 | 53 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 51 participants | 53 participants | 52 participants | 156.0 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 30 Participants | 79 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 22 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 51 | 0 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 | 0 / 53 |
Outcome results
Primary
Verbal Pain Score
11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain
Time frame: Immediately after injection of study drug. One time assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Verbal Pain Score | 3 Units on a scale |
| Lidocaine / Propofol Admixture Arm | Verbal Pain Score | 0 Units on a scale |
| Lidocaine Pretreatment Arm | Verbal Pain Score | 0 Units on a scale |
Comparison: Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.p-value: <0.0001Kruskal-Wallis
Secondary
Complete Alleviation of Injection Pain
Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)
Time frame: Immediately after injection of study drug. One time assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Complete Alleviation of Injection Pain | 14 Participants |
| Lidocaine / Propofol Admixture Arm | Complete Alleviation of Injection Pain | 28 Participants |
| Lidocaine Pretreatment Arm | Complete Alleviation of Injection Pain | 40 Participants |
p-value: <0.008Chi-squared
Secondary
Satisfaction With Anesthetic Technique
Were you satisfied with the anesthetic technique? Yes/No
Time frame: Prior to discharge. One time assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm | Satisfaction With Anesthetic Technique | No | 8 Participants |
| Control Arm | Satisfaction With Anesthetic Technique | Yes | 42 Participants |
| Lidocaine / Propofol Admixture Arm | Satisfaction With Anesthetic Technique | No | 2 Participants |
| Lidocaine / Propofol Admixture Arm | Satisfaction With Anesthetic Technique | Yes | 48 Participants |
| Lidocaine Pretreatment Arm | Satisfaction With Anesthetic Technique | Yes | 51 Participants |
| Lidocaine Pretreatment Arm | Satisfaction With Anesthetic Technique | No | 0 Participants |