Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

NCT05984264 | Unknown Phase 4

• 1 other identifier: BBBAAS
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pridocaine cream

EXPERIMENTAL

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.

Standardized local lidocaine infiltration

ACTIVE COMPARATOR

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.

Interventions

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

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.

Also known as: Pridocaine cream in pain management before pleurocentesis.

Pridocaine cream; Standardized local lidocaine infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients will be prepared for pleurocentesis.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University Hospital

Asyut, Assiut university 71515, Egypt

RECRUITING

Related Publications (13)

• 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.

  PMID: 32743311 BACKGROUND

• 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.

  PMID: 29698720 BACKGROUND

• 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.

  PMID: 28346035 BACKGROUND

• 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.

  PMID: 34249663 BACKGROUND

• 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.

  PMID: 29075099 BACKGROUND

• 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.

  PMID: 28653424 BACKGROUND

• 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.

  PMID: 29334290 BACKGROUND

• 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.

  PMID: 31423750 BACKGROUND

• 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.

  PMID: 16202900 BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

• 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.

  PMID: 29922408 BACKGROUND

• 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.

  PMID: 16320034 BACKGROUND

• 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.

  PMID: 26773187 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Interventions

Lidocaine; Prilocaine

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Safaa A Eid, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Safaa A Eid, MD

CONTACT

01002569966; safaa_gayed@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

EG (1)