Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Pleural Effusion Clinical Trial

Official title:

Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984264
• Other study ID #: BBBAAS
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Safaa A Eid, MD
• Phone: 01002569966
• Email: safaa_gayed[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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. — View 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. — View Citation

Cruickshank A, Qeadan F, Kuttesch JF, Agarwal HS. Eutectic mixture of lidocaine and prilocaine versus 1% lidocaine injection for lumbar punctures in pediatric oncology patients. Pediatr Blood Cancer. 2019 Nov;66(11):e27957. doi: 10.1002/pbc.27957. Epub 2019 Aug 18. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1. — View 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. — View 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. — View 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. — View Citation

Pirat A, Karaaslan P, Candan S, Zeyneloglu P, Varan B, Tokel K, Torgay A, Arslan G. Topical EMLA cream versus prilocaine infiltration for pediatric cardiac catheterization. J Cardiothorac Vasc Anesth. 2005 Oct;19(5):642-5. doi: 10.1053/j.jvca.2004.10.007. — View 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. — View 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. — View Citation

Tihan D, Totoz T, Tokocin M, Ercan G, Koc Calikoglu T, Vartanoglu T, Celebi F, Dandin O, Kafa IM. Efficacy of laparoscopic transversus abdominis plane block for elective laparoscopic cholecystectomy in elderly patients. Bosn J Basic Med Sci. 2016 Jan 14;16(2):139-44. doi: 10.17305/bjbms.2016.841. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of pain will be assessed using the visual analogue scale (VAS).	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).	one day