Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain

NCT03057704 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00040756
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Injections, Intravenous

Keywords

Propofol; lidocaine; pain

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (2)

• Subject's Recall of Injection Discomfort

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

• Investigators Rating of Patient Discomfort

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

Study Arms (2)

Intravenous lidocaine: flushed

ACTIVE COMPARATOR

Lidocaine injection flushed

Drug: Lidocaine injection flushed

Intravenous lidocaine: tourniquet

EXPERIMENTAL

Lidocaine injection tourniquet

Drug: Lidocaine injection tourniquet

Interventions

Lidocaine injection flushed DRUG

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

Also known as: Xylocaine

Intravenous lidocaine: flushed

Lidocaine injection tourniquet DRUG

Intravenous lidocaine: tourniquet

Also known as: Xylocaine, Tourniquet

Intravenous lidocaine: tourniquet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

North Carolina Baptist Hospital

Winston-Salem, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Tourniquets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Limitations and Caveats

Results became clear at total number of subject =25.

Results Point of Contact

• Title: Timothy N. Harwood MD
• Organization: Wake Forest University School of Medcine

tharwood@wakehealth.edu

3367164498

Study Officials

• Timothy N Harwood, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Patrick Grace, MD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: December 5, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: September 10, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)