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Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

Primary Purpose

Pleural Effusion

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All Patients will be prepared for pleurocentesis. Exclusion Criteria: 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).

Sites / Locations

  • Assuit University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pridocaine cream

Standardized local lidocaine infiltration

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05984264
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pridocaine cream
Arm Type
Experimental
Arm 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.
Arm Title
Standardized local lidocaine infiltration
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
lidocaine 2.5% and prilocaine 2.5% cream in pain management before pleurocentesis.
Other Intervention Name(s)
Pridocaine cream in pain management before pleurocentesis.
Intervention 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. 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.
Primary Outcome Measure Information:
Title
The severity of pain will be assessed using the visual analogue scale (VAS).
Description
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).
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All Patients will be prepared for pleurocentesis. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Safaa A Eid, MD
Phone
01002569966
Email
safaa_gayed@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safaa A Eid, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University Hospital
City
Assiut
ZIP/Postal Code
Assiut university 71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safaa A Eid, MD
Phone
01002569966
Email
safaa_gayed@aun.edu.eg

12. IPD Sharing Statement

Citations:
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32743311
Citation
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Results Reference
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Citation
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Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

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