Preventing Propofol-associated Injection Pain

• Sponsor: Benaroya Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00864682
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Saline; Drug: Lidocaine / propofol admixture; Drug: lidocaine pretreatment	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline pretreatment, saline admixture	Drug: Saline; 3.3 mL normal saline
Active Comparator: Lidocaine pretreatment Lidocaine pretreatment / saline-propofol admixture	Drug: lidocaine pretreatment; lidocaine 50 mg iv under tourniquet-control
Active Comparator: Lidocaine-Propofol admixture saline pretreatment / Lidocaine-propofol admixture	Drug: Lidocaine / propofol admixture; lidocaine 50 mg plus propofol 50 mg intravenous (iv)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. Satisfaction With Anesthetic Technique [Prior to discharge. One time assessment]

   Were you satisfied with the anesthetic technique? Yes/No

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benaroya Research Institute	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Benaroya Research Institute

Investigators

• Principal Investigator: Joseph M Neal, MD, Virginia Mason Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph Neal, PI, Benaroya Research Institute
• ClinicalTrials.gov Identifier: NCT00864682
• Other Study ID Numbers: 06091
• First Posted: Mar 19, 2009
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Joseph Neal, PI, Benaroya Research Institute: propofol; lidocaine; injection pain
• Additional relevant MeSH terms: Lidocaine; Propofol

Study Results

Participant Flow

Recruitment Details	Patients entered were recruited between January 2008 and March 2009. Hospital / ambulatory surgery setting

Arm/Group Title	Control Arm	Lidocaine / Propofol Admixture Arm	Lidocaine Pretreatment Arm
Arm/Group Description	saline pretreatment, saline plus propofol admixture	saline pretreatment, lidocaine plus propofol admixture	lidocaine pretreatment, saline plus propofol admixture
Period Title: Overall Study
STARTED	52	51	53
COMPLETED	50	50	51
NOT COMPLETED	2	1	2

Baseline Characteristics

Arm/Group Title	Control Arm	Lidocaine / Propofol Admixture Arm	Lidocaine Pretreatment Arm	Total
Arm/Group Description	saline pretreatment, saline plus propofol admixture	saline pretreatment, lidocaine plus propofol admixture	lidocaine pretreatment, saline plus propofol admixture	Total of all reporting groups
Overall Participants	52	51	53	156
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	42 80.8%	41 80.4%	38 71.7%	121 77.6%
>=65 years	10 19.2%	10 19.6%	15 28.3%	35 22.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (14)	54 (14)	52 (17)	53 (15)
Sex: Female, Male (Count of Participants)
Female	30 57.7%	23 45.1%	26 49.1%	79 50.6%
Male	22 42.3%	28 54.9%	27 50.9%	77 49.4%
Region of Enrollment (participants) [Number]
United States	52 100%	51 100%	53 100%	156.0 100%

Outcome Measures

1. Primary Outcome

Title	Verbal Pain Score
Description	11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain
Time Frame	Immediately after injection of study drug. One time assessment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Lidocaine / Propofol Admixture Arm	Lidocaine Pretreatment Arm
Arm/Group Description	saline pretreatment, saline plus propofol admixture	saline pretreatment, lidocaine plus propofol admixture	lidocaine pretreatment, saline plus propofol admixture
Measure Participants	50	50	51
Median (Inter-Quartile Range) [Units on a scale]	3	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Lidocaine / Propofol Admixture Arm, Lidocaine Pretreatment Arm
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

2. Secondary Outcome

Title	Complete Alleviation of Injection Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Lidocaine / Propofol Admixture Arm	Lidocaine Pretreatment Arm
Arm/Group Description	saline pretreatment, saline plus propofol admixture	saline pretreatment, lidocaine plus propofol admixture	lidocaine pretreatment, saline plus propofol admixture
Measure Participants	50	50	51
Number [Participants]	14 26.9%	28 54.9%	40 75.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Lidocaine / Propofol Admixture Arm, Lidocaine Pretreatment Arm
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.008
	Comments
	Method	Chi-squared
	Comments	Fisher's exact test after chi-squared

3. Secondary Outcome

Title	Satisfaction With Anesthetic Technique
Description	Were you satisfied with the anesthetic technique? Yes/No
Time Frame	Prior to discharge. One time assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Lidocaine / Propofol Admixture Arm	Lidocaine Pretreatment Arm
Arm/Group Description	saline pretreatment, saline plus propofol admixture	saline pretreatment, lidocaine plus propofol admixture	lidocaine pretreatment, saline plus propofol admixture
Measure Participants	50	50	51
Yes	42 80.8%	48 94.1%	51 96.2%
No	8 15.4%	2 3.9%	0 0%

Adverse Events

Arm/Group Title	Control Arm		Lidocaine / Propofol Admixture Arm		Lidocaine Pretreatment Arm
Arm/Group Description	saline pretreatment, saline plus propofol admixture		saline pretreatment, lidocaine plus propofol admixture		lidocaine pretreatment, saline plus propofol admixture
All Cause Mortality
	Control Arm		Lidocaine / Propofol Admixture Arm		Lidocaine Pretreatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Arm		Lidocaine / Propofol Admixture Arm		Lidocaine Pretreatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Lidocaine / Propofol Admixture Arm		Lidocaine Pretreatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)		0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.