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

NCT ID: NCT04779255

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-11-30

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)

Conditions

Pain; Actinic Keratosis; Analgesia; Phototerapy; Vertex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tumescent anesthesia

Patient who will receive tumescent anesthesia as analgesic treatment

Group Type: EXPERIMENTAL

Procedure (Tumesent anesthesia)

Intervention Type: DRUG

Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.

Painkillers and cold water

Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment

Group Type: ACTIVE_COMPARATOR

Control Arm (Paracetamol)

Intervention Type: DRUG

Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.

Interventions

Procedure (Tumesent anesthesia)

Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.

Intervention Type: DRUG

Control Arm (Paracetamol)

Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Damien BOUTIN, Dr

Role: CONTACT

damien.boutin@chu-poitiers.fr

05 49 44 44 59 ext. +33

Facility Contacts

BOUTIN Damien, MD

Role: primary

Other Identifiers

2021-000304-38

Identifier Type: -

Identifier Source: org_study_id