Injections, Intravenous Clinical Trial
Official title:
Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
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.
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.
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