NCT04356352

Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Terminated Phase 2, PHASE3 Results posted Last updated 19 September 2024

What this trial tests

Phase 2, PHASE3 trial testing Lidocaine in Injection Site Irritation in 33 participants. Terminated before completion.

Timeline

9 September 2020

Primary endpoint
25 August 2023

25 August 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	33
Start date	9 September 2020
Primary completion	25 August 2023
Estimated completion	25 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Lidocaine — full drug profile →
• Esmolol (ESMOLOL) — full drug profile →
• Placebo

Conditions studied

• Injection Site Irritation — all drugs for Injection Site Irritation →
• Pain — all drugs for Pain →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 60, any sex, with Injection Site Irritation or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Pain Score Primary · 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

Group	Value	95% CI
Lidocaine	0.45	± 0.66
Esmolol	0.5	± 1.02
Placebo	1.83	± 1.07

Heart Rate Secondary · 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

Minute 2

Group	Value	95% CI
Lidocaine	72.6	± 12.2
Esmolol	81	± 14.25
Placebo	82	± 11.15

Minute 3

Group	Value	95% CI
Lidocaine	72.4	± 14.18
Esmolol	82	± 17.46
Placebo	77.2	± 11.33

Minute 4

Group	Value	95% CI
Lidocaine	76.9	± 13.37
Esmolol	78.4	± 13.14
Placebo	79	± 11.5

Minute 5

Group	Value	95% CI
Lidocaine	76.8	± 16.99
Esmolol	91.7	± 26.54
Placebo	83.3	± 10.89

Minute 6

Group	Value	95% CI
Lidocaine	77.4	± 15.62
Esmolol	84	± 10.92
Placebo	86	± 10.13

Minute 7

Group	Value	95% CI
Lidocaine	83.3	± 24.25
Esmolol	89.5	± 12.41
Placebo	84.3	± 11.76

Minute 8

Group	Value	95% CI
Lidocaine	75.5	± 13.43
Esmolol	83.4	± 13.8
Placebo	80.5	± 10.75

Minute 9

Group	Value	95% CI
Lidocaine	73.6	± 15.46
Esmolol	85.2	± 8.98
Placebo	80.8	± 8.3

Systolic Blood Pressure Secondary · Systolic Blood Pressure is measured each minute for the first 10 minutes following induction

blood pressure measured in mmHg

Minute 2

Group	Value	95% CI
Lidocaine	122.7	± 18.15
Esmolol	126	± 26.45
Placebo	147.2	± 33.45

Minute 3

Group	Value	95% CI
Lidocaine	116.1	± 22.77
Esmolol	114	± 23.6
Placebo	153.3	± 31.78

Minute 4

Group	Value	95% CI
Lidocaine	121.6	± 12.19
Esmolol	112	± 20.52
Placebo	134.4	± 17.94

Minute 5

Group	Value	95% CI
Lidocaine	115.4	± 14.45
Esmolol	110.5	± 18.59
Placebo	123.8	± 21.47

Minute 6

Group	Value	95% CI
Lidocaine	117.9	± 10.31
Esmolol	138.6	± 29.79
Placebo	136.5	± 52.49

Minute 7

Group	Value	95% CI
Lidocaine	121.2	± 20.79
Esmolol	140.9	± 37.29
Placebo	128.8	± 37.33

Minute 8

Group	Value	95% CI
Lidocaine	113.8	± 15.52
Esmolol	127.1	± 27.54
Placebo	137	± 43.08

Minute 9

Group	Value	95% CI
Lidocaine	116.8	± 6.94
Esmolol	122.4	± 26.09
Placebo	126	± 29.81

Oxygen Saturation Percentage Secondary · Oxygen saturation measured each minute for the first 10 minutes following induction

oxygen saturation is measured on a percentage, with normal range \>90%

Minute 2

Group	Value	95% CI
Lidocaine	99.6	± 0.64
Esmolol	99.9	± 0.3
Placebo	99.8	± 0.37

Minute 3

Group	Value	95% CI
Lidocaine	99.6	± 0.64
Esmolol	99.89	± 0.31
Placebo	99.8	± 0.37

Minute 4

Group	Value	95% CI
Lidocaine	99.5	± 0.66
Esmolol	99.9	± 0.3
Placebo	99.8	± 0.37

Minute 5

Group	Value	95% CI
Lidocaine	99.2	± 1.19
Esmolol	99.9	± 0.3
Placebo	99.8	± 0.37

Minute 6

Group	Value	95% CI
Lidocaine	99.2	± 1.19
Esmolol	99.89	± 0.31
Placebo	99.2	± 0.9

Minute 7

Group	Value	95% CI
Lidocaine	99.2	± 1.19
Esmolol	99.7	± 0.46
Placebo	99.3	± 0.47

Minute 8

Group	Value	95% CI
Lidocaine	98.8	± 1.47
Esmolol	99.6	± 0.66
Placebo	99	± 1.16

Minute 9

Group	Value	95% CI
Lidocaine	99.2	± 1.19
Esmolol	99.9	± 0.31
Placebo	99.5	± 0.76

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.