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Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain

Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03057704
Enrollment
50
Registered
2017-02-20
Start date
2016-12-05
Completion date
2017-01-20
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injections, Intravenous

Keywords

Propofol, lidocaine, pain

Brief summary

Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent washing out of the lidocaine prior to propofol injection helps reduce propofol injection pain.

Detailed description

The investigators expect that tourniquet lidocaine is superior to straight non-tourniquet lidocaine in reducing propofol injection pain. The investigators also wanted to determine the association of tourniquet duration on reduction of pain with propofol administration. Small studies indicate that 60 seconds of tourniquet lidocaine is superior to 30 seconds or less of tourniquet duration or mixed lidocaine/propofol for injection. The investigators suspect many clinicians do not use the 60-second tourniquet technique due to the extra time involved but hypothesize that a more practical application by applying the tourniquet as soon as the patient is positioned on the operating table will not only be more widely adopted by clinicians as it does not cause delay but also provide the necessary amount of time for benefit from the tourniquet. The investigators also wanted to record the time from tourniquet application to start of propofol administration, which the investigators predict would be at least 60 seconds to see if there is a correlation between duration of venous stasis of IV lidocaine and pain benefit. Methods and Measures Design This was conducted as a randomized controlled trial of two methods of administering lidocaine prior to propofol injection. Setting The study setting was located within North Carolina Baptist Health, an academic medical center, in the Endoscopy Suite or Outpatient Surgery Center where subjects were scheduled to receive propofol as part of their sedation or anesthetic. Sample Size The investigators estimated that 25 subjects in each of the two groups was required to test the hypothesis based on prior studies. Interventions and Interactions The investigators used two groups: * Group 1: 50mg of 2% lidocaine given just prior to the propofol dose through the IV line. * Group 2: 50mg of 2% lidocaine given IV with venous occlusion applied when the patient is positioned on the operating room table and timed until the onset of propofol administration. The tourniquet the investigators used was a Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint in the tourniquet group. Venous stasis was confirmed with cessation of flow from hanging IV fluid. For both groups, no premedication was given, which is the normal practice for these procedures. Study procedures involved placing a 20 gauge intravenous (IV) catheter in a vein distal to the mid forearm. Venous occlusion was achieved by either a latex free tourniquet or McKesson Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint. Tourniquet pressure was somewhat variable but sufficient to cause venous stasis as confirmed by no flow of hanging IV fluid. Injections were delivered at roughly 1 ml/sec. Schedule of events in the study (all performed by 1 of the 2 investigators: * Day of procedure: holding area * Consent subject for study participation * Randomly assign patient to one of two groups * Day of procedure: procedure area -Accompany subject to the operating or procedure room, perform protocol from the group to which the subjects were assigned, while noting outcome measures such as self-described discomfort and observer graded discomfort * Day of procedure: recovery area -Revisit subject in recovery 30 minutes after their procedure to determine post-procedure recall of discomfort * Post-study period * Analyze data Analytical Plan The investigators will analyze results initially using descriptive statistics. Comparison between groups was done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables. Regression analysis was performed to identify independent outcome predictors. Other inferential statistical analysis was conducted as appropriate. Informed Consent One of the two investigators obtained signed informed consent from each subject. This was performed in the holding room prior to the procedure since most subjects had their pre-procedure examination performed in the holding room and were not seen prior to the day of their procedure.

Interventions

DRUGLidocaine injection flushed

The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.

DRUGLidocaine injection tourniquet

Intravenous lidocaine: tourniquet

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.

Intervention model description

A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection. * Cases must be schedule to have a duration less than 60 minutes.

Exclusion criteria

* Subjects are excluded if they cannot verbalize a rating of pain * Subjects are excluded if they require intravenous medications prior to the study period

Design outcomes

Primary

MeasureTime frameDescription
Patient Expression of PainDuring injection at beginning of study; lasts 10 seconds one time onlyPatient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

Secondary

MeasureTime frameDescription
Subject's Recall of Injection DiscomfortThis occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time onlyInvestigator asks patient if they recall discomfort during injection after the procedure. Patient's verbal rating and recall of pain during injection. We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).
Investigators Rating of Patient DiscomfortDuring injection at beginning of study period; lasts 10 seconds one time onlyInvestigator rates patient's nonverbal display of discomfort. Investigator Assessments: Induction Discomfort Scale (during injection and within 5 seconds after injection) * No change in patient behavior (0) * Grimace (1) * IV forearm withdrawal (2) * Moaning (3) * Verbal statement of discomfort (it hurts, etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.

Countries

United States

Participant flow

Recruitment details

Subjects were approached after they were scheduled for colonoscopy or minor procedures and appeared in the holding area for procedures in which propofol sedation or induction of general anesthesia was used.

Participants by arm

ArmCount
Intravenous Lidocaine: Flushed
Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.
25
Intravenous Lidocaine: Tourniquet
Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet
25
Total50

Baseline characteristics

CharacteristicTotalIntravenous Lidocaine: FlushedIntravenous Lidocaine: Tourniquet
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants2 Participants3 Participants
Age, Categorical
Between 18 and 65 years
45 Participants23 Participants22 Participants
Age, Continuous53 years
STANDARD_DEVIATION 7.1
52 years
STANDARD_DEVIATION 6.9
54 years
STANDARD_DEVIATION 7.3
Pain score at IV prior to procedure
IV pain score of 0
50 Participants25 Participants25 Participants
Pain score at IV prior to procedure
IV pain score of 1-3
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
17 Participants9 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants13 Participants14 Participants
Region of Enrollment
United States
50 participants25 participants25 participants
Sex: Female, Male
Female
33 Participants15 Participants18 Participants
Sex: Female, Male
Male
17 Participants10 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Patient Expression of Pain

Patient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

Time frame: During injection at beginning of study; lasts 10 seconds one time only

ArmMeasureValue (MEAN)Dispersion
Intravenous Lidocaine: FlushedPatient Expression of Pain0.76 units on a scaleStandard Deviation 1
Intravenous Lidocaine: TourniquetPatient Expression of Pain0.04 units on a scaleStandard Deviation 0.2
Secondary

Investigators Rating of Patient Discomfort

Investigator rates patient's nonverbal display of discomfort. Investigator Assessments: Induction Discomfort Scale (during injection and within 5 seconds after injection) * No change in patient behavior (0) * Grimace (1) * IV forearm withdrawal (2) * Moaning (3) * Verbal statement of discomfort (it hurts, etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.

Time frame: During injection at beginning of study period; lasts 10 seconds one time only

ArmMeasureValue (MEAN)Dispersion
Intravenous Lidocaine: FlushedInvestigators Rating of Patient Discomfort1.12 units on a scaleStandard Deviation 1.27
Intravenous Lidocaine: TourniquetInvestigators Rating of Patient Discomfort0 units on a scaleStandard Deviation 0
Secondary

Subject's Recall of Injection Discomfort

Investigator asks patient if they recall discomfort during injection after the procedure. Patient's verbal rating and recall of pain during injection. We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

Time frame: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only

ArmMeasureValue (MEAN)Dispersion
Intravenous Lidocaine: FlushedSubject's Recall of Injection Discomfort0.52 units on a scaleStandard Deviation 0.82
Intravenous Lidocaine: TourniquetSubject's Recall of Injection Discomfort0.04 units on a scaleStandard Deviation 0.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026