Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain

• ClinicalTrials.gov Identifier: NCT03057704
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Results First Posted: February 13, 2018
• Last Update Posted: September 10, 2018
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Injections, Intravenous	Drug: Lidocaine injection flushed; Drug: Lidocaine injection tourniquet	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
• Masking: Single (Participant)
• 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.
• Primary Purpose: Treatment
• Official Title: Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
• Actual Study Start Date: December 5, 2016
• Actual Primary Completion Date: January 20, 2017
• Actual Study Completion Date: January 20, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intravenous lidocaine: flushed; Lidocaine injection flushed	Drug: Lidocaine injection flushed; The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.; Other Name: Xylocaine
Experimental: Intravenous lidocaine: tourniquet; Lidocaine injection tourniquet	Drug: Lidocaine injection tourniquet; Intravenous lidocaine: tourniquet; Other Names: Xylocaine; Tourniquet

Outcome Measures

Primary Outcome Measures :

1. Patient Expression of Pain [ Time Frame: During injection at beginning of study; lasts 10 seconds one time only ]

   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).

Secondary Outcome Measures :

1. Subject's Recall of Injection Discomfort [ Time Frame: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only ]

   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).
2. Investigators Rating of Patient Discomfort [ Time Frame: During injection at beginning of study period; lasts 10 seconds one time only ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

North Carolina Baptist Hospital

Winston-Salem, North Carolina, United States, 27612

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Timothy N Harwood, MD; Wake Forest University Health Sciences
• Study Director: Patrick Grace, MD; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 30, 2016

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03057704
• Other Study ID Numbers: IRB00040756
• First Posted: February 20, 2017
• Results First Posted: February 13, 2018
• Last Update Posted: September 10, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Wake Forest University Health Sciences:

Propofol; lidocaine; pain

Additional relevant MeSH terms:

Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action