Synera Venipuncture Pain

NCT01744197 | Completed Phase 2 Results

• 1 other identifier: 12112
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS

Conditions

Pain; Phlebotomy; Palliative Care

Keywords

Pain control; Needle stick pain; Venipuncture pain

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With No or Minor Pain (VAS<3)

  The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS \<3 is considered as patients with no or minor pain and would be compared between 2 groups.

  30 minutes after the venipuncture.

• Percentage of Patients With No Pain (VAS=0)

  The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.

  30 minutes after the venipuncture.

Secondary Outcomes (1)

• Global Assessment of Satisfaction With Venipuncture

  30 minutes after the venipuncture.

Study Arms (2)

Arm 1

EXPERIMENTAL

First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch

Drug: Synera (lidocaine 70mg/tetracaine 70mg)

Arm 2

EXPERIMENTAL

First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch

Drug: Synera (lidocaine 70mg/tetracaine 70mg)

Interventions

Synera (lidocaine 70mg/tetracaine 70mg) DRUG

All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Also known as: Synera

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
• Is 18 years of age or older.
• Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
• Male or female patients
• Has signed the most recent Patient Informed Consent Form
• Has signed a Patient Authorization Form (HIPPA)

You may not qualify if:

• Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
• Known sensitivity to any components of test materials (sulphites and adhesives)
• Patients with damaged or broken skin at the designated patch site
• Pregnant or breastfeeding women patients
• Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit
• Previous irradiation to the site of the patch

Sponsors & Collaborators

• US Oncology Research: lead
• Nuvo Research Inc.: collaborator

Study Sites (1)

19 Locations Including

Dallas, Texas, United States

Location

Related Publications (2)

• Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):507-13. doi: 10.1097/AAP.0b013e3181fa69b8.

  PMID: 20975464 RESULT

• Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/bja/aen364.

  PMID: 19151049 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine; Tetracaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Melanie Matson, RN, BSN
• Organization: Evergreen Hematology and Oncology

mmatson@evergreen4cure.com

5094642873

Study Officials

• Melanie Matson, RN, BSN

  US Oncology Research, McKesson Specialty Health

  PRINCIPAL INVESTIGATOR

• Laura T. Guerra, RN

  US Oncology Research, McKesson Specialty Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 25, 2018
• Results First Posted: February 17, 2016

Record last verified: 2018-09

Locations

US (1)