Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Assiut University

Status and phase: Enrolling; Phase 4

Conditions: Pleural Effusion

Treatments: Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.

Study type: Interventional

Funder types: Other

Identifiers

NCT05984264

BBBAAS

Details and patient eligibility

About

The research aims to compare the efficacy of topical Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) and the standardized local lidocaine infiltration in pain management before pleurocentesis.

Full description

Acute pain management is a core ethical concept in medical practice. During pleurocentesis, the standardized pain management is with 1% lidocaine with a 25 gauge needle for skin and a smaller gauge needle for deeper tissue. As the anesthetic injection is painful in and of itself, during these two procedures, pain management can sometimes fall short due to a lack of education and incorrect personal opinions. One example is "one needle insertion can cause less pain than two-needle insertions". Therefore, it is essential to find an alternative method that is painless and reduces procedural pain, which does not require expertise to administer. This is particularly important in centers with a high volume of patients and a lack of expert medical staff.

Another option for administering a local anesthesia is using a topical anesthetic. Generally, these are easily applied, tolerated better by patients, and have minimal systemic absorption resulting in fewer side effects6. A topical anesthetic can be a substitute for infiltrative lidocaine (IL) if it can be effective in reducing pain. Lidocaine-prilocaine cream (LPC) is an example of a topical anesthetic, which was introduced in 1980 for dermabrasion and minor surgery.

Previous research findings had noted the efficacy of LPC compared to IL in trans-radial catheterization, perineal tears following vaginal delivery, and some pediatric procedures like lumbar punctures and venipunctures. Additionally, LPC can be substituted for infiltrative prilocaine in pediatric femoral catheterization.

Hanieh Halili et al, found a significant difference between the LPC and IL groups in terms of patient pain or satisfaction levels, but their study was on a small sample size and they recommended further studies.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All Patients will be prepared for pleurocentesis.

Exclusion criteria

1. Patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
2. Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Pridocaine cream

Experimental group

Description:

Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) will be applied at least 30 min before the pleurocentesis on the skin overlying the chosen aspiration site using ultrasound under occlusive dressing over a 5 × 5 cm area.

Treatment:

Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.

Standardized local lidocaine infiltration

Active Comparator group

Description:

Anesthetize the skin over the insertion site with 1% lidocaine using the 5 ml syringe with a 25 or 27-gauge needle. Next, anesthetize the superior surface of the rib and the pleura. The needle is inserted over the top of the rib (superior margin) to avoid the intercostal nerves and blood vessels that run on the underside of the rib (the intercostal nerve and the blood supply are located near the inferior margin). As the needle is inserted, aspirate back on the syringe to check for pleural fluid. Once fluid returns, note the depth of the needle and mark it with a hemostat. This gives an approximate depth for the insertion of the thoracentesis needle. Remove the anesthetizing needle.

Treatment:

Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.