Topical Lidocaine for Needle Insertion and Injection Pain

Needle Insertion and Injection Pain Clinical Trial

Official title:

Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03206320
• Other study ID #: SMBe1701
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2017
• Last updated: September 26, 2017
• Start date: December 5, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: September 2017
• Source: New York School of Regional Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations

• Age >18 at the time of informed consent

• ASA I-III physical class

• Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block

Exclusion Criteria:

• History of an allergy or contra-indication to a local anesthetic

• Baseline neurological deficit

• Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member

• Presence of preexisting coagulation disorders

• Infection at injection site

• Concomitant opioid therapy

• Recent history (<3 months) of drug or alcohol abuse

• Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit

Related Conditions & MeSH terms

• Needle Insertion and Injection Pain

Intervention

Drug:
• Lidocaine Topical
Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
New York School of Regional Anesthesia

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle insertion pain	Pain rating (VAS)	Immediately at the time the needle is inserted through the skin
Primary	Injection pain	Pain rating (VAS)	Immediately at the end of the block
Secondary	Fearfulness	Likert scale from "1" (no fear) to "5" (very fearful)	Just before the nerve block
Secondary	Overall discomfort	Verbal rating scale from "0" (more comfortable/less painful than expected) to "10" (less comfortable/more painful than expected)	Immediately at the end of the block