Needle Insertion and Injection Pain
Conditions
Brief 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.
Interventions
Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain
Sponsors
New York School of Regional Anesthesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle insertion pain | Immediately at the time the needle is inserted through the skin | Pain rating (VAS) |
| Injection pain | Immediately at the end of the block | Pain rating (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fearfulness | Just before the nerve block | Likert scale from 1 (no fear) to 5 (very fearful) |
| Overall discomfort | Immediately at the end of the block | Verbal rating scale from 0 (more comfortable/less painful than expected) to 10 (less comfortable/more painful than expected) |
Countries
Belgium
Outcome results
None listed