Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest

Not Applicable

• Conditions: Vertex; Pain; Actinic Keratosis; Analgesia; Phototerapy
• Interventions: Drug: Procedure (Tumesent anesthesia); Drug: Control Arm (Paracetamol)

• Registration Number: NCT04779255
• Lead Sponsor: Poitiers University Hospital

Brief Summary

This study focus on the efficacity of tumescent anesthesia in pain management during a photodynamic therapy on the vertex for treatment of actinic keratosis. To do this we carried out a prospective, randomized, controlled, open-ended study. Our aim is to show a 40% reduction in pain during photodynamic therapy session compared to a conventionally used analgesic method (paracetamol + cold water)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Study Start: 2021-07-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients over the age of 18
• Diagnosis of clinical or histological actintic keratoses validated by a dermatologist
• More than 4 vertex actinic keratoses lesions that can be treated with a dynamic phototherapy session
• Free subject, without guardianship or curatorship or subordination
• Person affiliated or beneficiary of a social security plan
• Informed and signed consent by the patient after clear and fair information about the study

Exclusion Criteria

• Known lidocaine hydrochlostate hypersensitivity, local amide-binding anesthetics or one of the excipients
• Hypersensitivity to paracetamol or one of the excipients
• Weight < 50 kg
• Patients with an elongated TQ interval at the ECG (>450 ms in men and >470 ms in women)
• Patients with recurrent porphyria
• Severe hepato-cellular insufficient patients
• Patients who have received treatment for actinic keratoses in the last three months (cryotherapy, 5-fluorouracil, imiquinod, daylight-PTD)
• Patients who have already participated in this study
• People who do not have a social security plan or do not benefit from it through a third party.
• Persons with enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally the sick in an emergency situation.
• Pregnant or lactating women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per bone, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
• Concurrent participation in another clinical research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumescent anesthesia	Procedure (Tumesent anesthesia)	Patient who will receive tumescent anesthesia as analgesic treatment
Painkillers and cold water	Control Arm (Paracetamol)	Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measure : evaluate the effectiveness of tumescent anesthesia compared to the control group in pain management during a dynamic vertex phototherapy session performed for the management of actinic keratoses.	8 minutes	Score of the maximum numerical pain assessment scale from 0 to 10 (0=no pain; 10= pain as bas as can be) felt during the dynamic phototherapy session in both groups.; This score will be collected at the end of the session.

Trial Locations

Locations (1)

CHU; 🇫🇷 Poitiers, France