Clinical trial NCT05984264: Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis
Official title: Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pleural Effusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The severity of pain will be assessed using the visual analogue scale (VAS).
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University Hospital
Study officials:
affiliation: Assiut University
name: Safaa A Eid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akbar N, Teo SP, Artini Hj-Abdul-Rahman HN, Hj-Husaini HA, Venkatasalu MR. Barriers and Solutions for Improving Pain Management Practices in Acute Hospital Settings: Perspectives of Healthcare Practitioners for a Pain-Free Hospital Initiative. Ann Geriatr Med Res. 2019 Dec;23(4):190-196. doi: 10.4235/agmr.19.0037. Epub 2019 Dec 23.
citation: Patel BK, Wendlandt BN, Wolfe KS, Patel SB, Doman ER, Pohlman AS, Hall JB, Kress JP. Comparison of Two Lidocaine Administration Techniques on Perceived Pain From Bedside Procedures: A Randomized Clinical Trial. Chest. 2018 Oct;154(4):773-780. doi: 10.1016/j.chest.2018.04.018. Epub 2018 Apr 24.
citation: Story M. One Needle is Better Than Two: The Philosophy Surrounding Use of Local Anesthesia in Northern India. J Pain Palliat Care Pharmacother. 2017 Jun;31(2):162-164. doi: 10.1080/15360288.2017.1298687. Epub 2017 Mar 27.
citation: Halili H, Azizkhani R, Tavakoli Garmaseh S, Jafarpisheh MS, Heydari F, Masoumi B, Maghami Mehr A. Comparing the Effect of Lidocaine-Prilocaine Cream and Infiltrative Lidocaine on Overall Pain Perception During Thoracentesis and Abdominocentesis: A Randomized Clinical Trial. Anesth Pain Med. 2020 Nov 18;11(1):e106275. doi: 10.5812/aapm.106275. eCollection 2021 Feb.
citation: You P, Yuan R, Chen C. Design and evaluation of lidocaine- and prilocaine-coloaded nanoparticulate drug delivery systems for topical anesthetic analgesic therapy: a comparison between solid lipid nanoparticles and nanostructured lipid carriers. Drug Des Devel Ther. 2017 Sep 18;11:2743-2752. doi: 10.2147/DDDT.S141031. eCollection 2017.
citation: Latsios G, Toutouzas K, Antonopoulos AS, Melidi E, Synetos A, Vogiatzi G, Stasinopoulou A, Tsioufis K, Tsiamis E, Tousoulis D. Anesthetic ointment only (lidocaine/prilocaine) instead of injectable local lidocaine in trans-radial catheterization: A viable no-needle alternative. J Interv Cardiol. 2017 Aug;30(4):382-386. doi: 10.1111/joic.12399. Epub 2017 Jun 26.
citation: Abbas AM, Abdel Hafiz HA, Abdelhafez AM, Michael A, Ismail AM. Topical lidocaine-prilocaine cream versus lidocaine infiltration for pain relief during repair of perineal tears after vaginal delivery: randomized clinical trial. J Matern Fetal Neonatal Med. 2019 Jul;32(13):2182-2187. doi: 10.1080/14767058.2018.1428304. Epub 2018 Jan 31.
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citation: Qureshi AI, Saleem MA, Naseem N, Aytac E, Akpinar CK, Wallery SS. Effectiveness of Topical Lidocaine-Prilocaine Cream for Pain Control During Femoral Artery Catheterization in Adult Patients: A Prospective Study. J Vasc Interv Neurol. 2018 Jun;10(1):60-64.
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