Clincosm LogoSign in Get a demo

Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05984264
Collaborator
(none)
118
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pridocaine cream

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.

Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.
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. The time interval between topical Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) application and pleural aspiration will be 30 min, and 45 min.
Other Names:
  • Pridocaine cream in pain management before pleurocentesis.

    		•
    Active Comparator: Standardized local lidocaine infiltration

    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.

    Drug: lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.
    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. The time interval between topical Pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) application and pleural aspiration will be 30 min, and 45 min.
    Other Names:
  • Pridocaine cream in pain management before pleurocentesis.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The severity of pain will be assessed using the visual analogue scale (VAS). [one day]

      The severity of pain will be assessed using the visual analogue scale (VAS). The VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit University Hospital Assiut Egypt Assiut university 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Safaa A Eid, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Safaa Abd El-gayed Eid, Fellow, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05984264
    Other Study ID Numbers:
    • BBBAAS
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pleural Effusion
    Lidocaine
    Prilocaine

    Study Results

    No Results Posted as of Aug 9, 2023