Injection Site Irritation, Pain
Conditions
Brief summary
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool
Detailed description
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered
Interventions
DRUGLidocaine
1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
DRUGEsmolol
0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
OTHERPlacebo
saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
assessor asking for pain scores will be blinded from the randomization
Intervention model description
subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18-60 years of age * ASA 1-3 * Elective surgical procedure
Exclusion criteria
* BMI ≥ 45 * Pregnancy * Requirement for RSI or awake intubation * Suspected or known difficult airway * Contraindication to IV in either upper extremity * Chronic pain syndrome including fibromyalgia * Use of opioids, NSAIDs, or other analgesics within 24 hours (including preoperative PO Celebrex, Lyrica, Tylenol, etc.) * Any use of opioids in the past three months * Significant cardiopulmonary or hepatic dysfunction * Hypersensitivity to study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Score | following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction | pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | heart rate is measured each minute for the first 10 minutes following induction | heart rate is measured as numbers on a scale with normal 60-100 |
| Systolic Blood Pressure | Systolic Blood Pressure is measured each minute for the first 10 minutes following induction | blood pressure measured in mmHg |
| Oxygen Saturation Percentage | Oxygen saturation measured each minute for the first 10 minutes following induction | oxygen saturation is measured on a percentage, with normal range \>90% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine 1 mg/kg lidocaine to a max of 100 mg
Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | 13 |
| Esmolol 0.5 mg/kg esmolol to a max of 50 mg
Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | 13 |
| Placebo Saline water
Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | 7 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | PIV in location that was excluded, surgery cancelled | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Lidocaine | Total | Placebo | Esmolol |
|---|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 10.21 | 47.39 years STANDARD_DEVIATION 12.14 | 48.57 years STANDARD_DEVIATION 10.76 | 44.9 years STANDARD_DEVIATION 14.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 15 Participants | 5 Participants | 0 Participants |
| Region of Enrollment United States | 13 participants | 33 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 10 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 6 |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 6 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 6 |
Outcome results
Primary
Patient Pain Score
pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
Time frame: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Patient Pain Score | 0.45 score on a scale | Standard Deviation 0.66 |
| Esmolol | Patient Pain Score | 0.5 score on a scale | Standard Deviation 1.02 |
| Placebo | Patient Pain Score | 1.83 score on a scale | Standard Deviation 1.07 |
Secondary
Heart Rate
heart rate is measured as numbers on a scale with normal 60-100
Time frame: heart rate is measured each minute for the first 10 minutes following induction
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine | Heart Rate | Minute 5 | 76.8 beats per minute | Standard Deviation 16.99 |
| Lidocaine | Heart Rate | Minute 10 | 72.18 beats per minute | Standard Deviation 17.02 |
| Lidocaine | Heart Rate | Minute 7 | 83.3 beats per minute | Standard Deviation 24.25 |
| Lidocaine | Heart Rate | Minute 6 | 77.4 beats per minute | Standard Deviation 15.62 |
| Lidocaine | Heart Rate | Minute 2 | 72.6 beats per minute | Standard Deviation 12.2 |
| Lidocaine | Heart Rate | Minute 9 | 73.6 beats per minute | Standard Deviation 15.46 |
| Lidocaine | Heart Rate | Minute 4 | 76.9 beats per minute | Standard Deviation 13.37 |
| Lidocaine | Heart Rate | Minute 3 | 72.4 beats per minute | Standard Deviation 14.18 |
| Lidocaine | Heart Rate | Minute 8 | 75.5 beats per minute | Standard Deviation 13.43 |
| Esmolol | Heart Rate | Minute 6 | 84 beats per minute | Standard Deviation 10.92 |
| Esmolol | Heart Rate | Minute 2 | 81 beats per minute | Standard Deviation 14.25 |
| Esmolol | Heart Rate | Minute 3 | 82 beats per minute | Standard Deviation 17.46 |
| Esmolol | Heart Rate | Minute 4 | 78.4 beats per minute | Standard Deviation 13.14 |
| Esmolol | Heart Rate | Minute 5 | 91.7 beats per minute | Standard Deviation 26.54 |
| Esmolol | Heart Rate | Minute 7 | 89.5 beats per minute | Standard Deviation 12.41 |
| Esmolol | Heart Rate | Minute 8 | 83.4 beats per minute | Standard Deviation 13.8 |
| Esmolol | Heart Rate | Minute 9 | 85.2 beats per minute | Standard Deviation 8.98 |
| Esmolol | Heart Rate | Minute 10 | 80.2 beats per minute | Standard Deviation 12.59 |
| Placebo | Heart Rate | Minute 4 | 79 beats per minute | Standard Deviation 11.5 |
| Placebo | Heart Rate | Minute 2 | 82 beats per minute | Standard Deviation 11.15 |
| Placebo | Heart Rate | Minute 8 | 80.5 beats per minute | Standard Deviation 10.75 |
| Placebo | Heart Rate | Minute 3 | 77.2 beats per minute | Standard Deviation 11.33 |
| Placebo | Heart Rate | Minute 10 | 83.7 beats per minute | Standard Deviation 21.05 |
| Placebo | Heart Rate | Minute 6 | 86 beats per minute | Standard Deviation 10.13 |
| Placebo | Heart Rate | Minute 5 | 83.3 beats per minute | Standard Deviation 10.89 |
| Placebo | Heart Rate | Minute 9 | 80.8 beats per minute | Standard Deviation 8.3 |
| Placebo | Heart Rate | Minute 7 | 84.3 beats per minute | Standard Deviation 11.76 |
Secondary
Oxygen Saturation Percentage
oxygen saturation is measured on a percentage, with normal range \>90%
Time frame: Oxygen saturation measured each minute for the first 10 minutes following induction
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine | Oxygen Saturation Percentage | Minute 5 | 99.2 percentage | Standard Deviation 1.19 |
| Lidocaine | Oxygen Saturation Percentage | Minute 10 | 99.3 percentage | Standard Deviation 1.14 |
| Lidocaine | Oxygen Saturation Percentage | Minute 7 | 99.2 percentage | Standard Deviation 1.19 |
| Lidocaine | Oxygen Saturation Percentage | Minute 6 | 99.2 percentage | Standard Deviation 1.19 |
| Lidocaine | Oxygen Saturation Percentage | Minute 2 | 99.6 percentage | Standard Deviation 0.64 |
| Lidocaine | Oxygen Saturation Percentage | Minute 9 | 99.2 percentage | Standard Deviation 1.19 |
| Lidocaine | Oxygen Saturation Percentage | Minute 4 | 99.5 percentage | Standard Deviation 0.66 |
| Lidocaine | Oxygen Saturation Percentage | Minute 3 | 99.6 percentage | Standard Deviation 0.64 |
| Lidocaine | Oxygen Saturation Percentage | Minute 8 | 98.8 percentage | Standard Deviation 1.47 |
| Esmolol | Oxygen Saturation Percentage | Minute 6 | 99.89 percentage | Standard Deviation 0.31 |
| Esmolol | Oxygen Saturation Percentage | Minute 2 | 99.9 percentage | Standard Deviation 0.3 |
| Esmolol | Oxygen Saturation Percentage | Minute 3 | 99.89 percentage | Standard Deviation 0.31 |
| Esmolol | Oxygen Saturation Percentage | Minute 4 | 99.9 percentage | Standard Deviation 0.3 |
| Esmolol | Oxygen Saturation Percentage | Minute 5 | 99.9 percentage | Standard Deviation 0.3 |
| Esmolol | Oxygen Saturation Percentage | Minute 7 | 99.7 percentage | Standard Deviation 0.46 |
| Esmolol | Oxygen Saturation Percentage | Minute 8 | 99.6 percentage | Standard Deviation 0.66 |
| Esmolol | Oxygen Saturation Percentage | Minute 9 | 99.9 percentage | Standard Deviation 0.31 |
| Esmolol | Oxygen Saturation Percentage | Minute 10 | 99.7 percentage | Standard Deviation 0.64 |
| Placebo | Oxygen Saturation Percentage | Minute 4 | 99.8 percentage | Standard Deviation 0.37 |
| Placebo | Oxygen Saturation Percentage | Minute 2 | 99.8 percentage | Standard Deviation 0.37 |
| Placebo | Oxygen Saturation Percentage | Minute 8 | 99 percentage | Standard Deviation 1.16 |
| Placebo | Oxygen Saturation Percentage | Minute 3 | 99.8 percentage | Standard Deviation 0.37 |
| Placebo | Oxygen Saturation Percentage | Minute 10 | 99.3 percentage | Standard Deviation 0.94 |
| Placebo | Oxygen Saturation Percentage | Minute 6 | 99.2 percentage | Standard Deviation 0.9 |
| Placebo | Oxygen Saturation Percentage | Minute 5 | 99.8 percentage | Standard Deviation 0.37 |
| Placebo | Oxygen Saturation Percentage | Minute 9 | 99.5 percentage | Standard Deviation 0.76 |
| Placebo | Oxygen Saturation Percentage | Minute 7 | 99.3 percentage | Standard Deviation 0.47 |
Secondary
Systolic Blood Pressure
blood pressure measured in mmHg
Time frame: Systolic Blood Pressure is measured each minute for the first 10 minutes following induction
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine | Systolic Blood Pressure | Minute 5 | 115.4 mm Hg (millimeters of mercury) | Standard Deviation 14.45 |
| Lidocaine | Systolic Blood Pressure | Minute 10 | 108 mm Hg (millimeters of mercury) | Standard Deviation 12.17 |
| Lidocaine | Systolic Blood Pressure | Minute 7 | 121.2 mm Hg (millimeters of mercury) | Standard Deviation 20.79 |
| Lidocaine | Systolic Blood Pressure | Minute 6 | 117.9 mm Hg (millimeters of mercury) | Standard Deviation 10.31 |
| Lidocaine | Systolic Blood Pressure | Minute 2 | 122.7 mm Hg (millimeters of mercury) | Standard Deviation 18.15 |
| Lidocaine | Systolic Blood Pressure | Minute 9 | 116.8 mm Hg (millimeters of mercury) | Standard Deviation 6.94 |
| Lidocaine | Systolic Blood Pressure | Minute 4 | 121.6 mm Hg (millimeters of mercury) | Standard Deviation 12.19 |
| Lidocaine | Systolic Blood Pressure | Minute 3 | 116.1 mm Hg (millimeters of mercury) | Standard Deviation 22.77 |
| Lidocaine | Systolic Blood Pressure | Minute 8 | 113.8 mm Hg (millimeters of mercury) | Standard Deviation 15.52 |
| Esmolol | Systolic Blood Pressure | Minute 6 | 138.6 mm Hg (millimeters of mercury) | Standard Deviation 29.79 |
| Esmolol | Systolic Blood Pressure | Minute 2 | 126 mm Hg (millimeters of mercury) | Standard Deviation 26.45 |
| Esmolol | Systolic Blood Pressure | Minute 3 | 114 mm Hg (millimeters of mercury) | Standard Deviation 23.6 |
| Esmolol | Systolic Blood Pressure | Minute 4 | 112 mm Hg (millimeters of mercury) | Standard Deviation 20.52 |
| Esmolol | Systolic Blood Pressure | Minute 5 | 110.5 mm Hg (millimeters of mercury) | Standard Deviation 18.59 |
| Esmolol | Systolic Blood Pressure | Minute 7 | 140.9 mm Hg (millimeters of mercury) | Standard Deviation 37.29 |
| Esmolol | Systolic Blood Pressure | Minute 8 | 127.1 mm Hg (millimeters of mercury) | Standard Deviation 27.54 |
| Esmolol | Systolic Blood Pressure | Minute 9 | 122.4 mm Hg (millimeters of mercury) | Standard Deviation 26.09 |
| Esmolol | Systolic Blood Pressure | Minute 10 | 117 mm Hg (millimeters of mercury) | Standard Deviation 18.42 |
| Placebo | Systolic Blood Pressure | Minute 4 | 134.4 mm Hg (millimeters of mercury) | Standard Deviation 17.94 |
| Placebo | Systolic Blood Pressure | Minute 2 | 147.2 mm Hg (millimeters of mercury) | Standard Deviation 33.45 |
| Placebo | Systolic Blood Pressure | Minute 8 | 137 mm Hg (millimeters of mercury) | Standard Deviation 43.08 |
| Placebo | Systolic Blood Pressure | Minute 3 | 153.3 mm Hg (millimeters of mercury) | Standard Deviation 31.78 |
| Placebo | Systolic Blood Pressure | Minute 10 | 128.4 mm Hg (millimeters of mercury) | Standard Deviation 30.88 |
| Placebo | Systolic Blood Pressure | Minute 6 | 136.5 mm Hg (millimeters of mercury) | Standard Deviation 52.49 |
| Placebo | Systolic Blood Pressure | Minute 5 | 123.8 mm Hg (millimeters of mercury) | Standard Deviation 21.47 |
| Placebo | Systolic Blood Pressure | Minute 9 | 126 mm Hg (millimeters of mercury) | Standard Deviation 29.81 |
| Placebo | Systolic Blood Pressure | Minute 7 | 128.8 mm Hg (millimeters of mercury) | Standard Deviation 37.33 |