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

NCT04779255 | Unknown

• 1 other identifier: 2021-000304-38
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 minutes

Study Arms (2)

Tumescent anesthesia

EXPERIMENTAL

Patient who will receive tumescent anesthesia as analgesic treatment

Drug: Procedure (Tumesent anesthesia)

Painkillers and cold water

ACTIVE COMPARATOR

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

Drug: Control Arm (Paracetamol)

Interventions

Procedure (Tumesent anesthesia) DRUG

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

Tumescent anesthesia

Control Arm (Paracetamol) DRUG

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

Painkillers and cold water

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Pain; Keratosis, Actinic; Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Damien BOUTIN, Dr

CONTACT

05 49 44 44 59; damien.boutin@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: July 28, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

FR (1)