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

Primary Purpose

Pain, Actinic Keratosis, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Procedure (Tumesent anesthesia)
Control Arm (Paracetamol)
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

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

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.

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tumescent anesthesia

Painkillers and cold water

Arm Description

Patient who will receive tumescent anesthesia as analgesic treatment

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2021
Last Updated
September 28, 2021
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04779255
Brief Title
Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest
Acronym
ANTUKA
Official Title
Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Actinic Keratosis, Analgesia, Phototerapy, Vertex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumescent anesthesia
Arm Type
Experimental
Arm Description
Patient who will receive tumescent anesthesia as analgesic treatment
Arm Title
Painkillers and cold water
Arm Type
Active Comparator
Arm Description
Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment
Intervention Type
Drug
Intervention Name(s)
Procedure (Tumesent anesthesia)
Intervention Description
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
Intervention Name(s)
Control Arm (Paracetamol)
Intervention Description
Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
8 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien BOUTIN, Dr
Phone
05 49 44 44 59
Ext
+33
Email
damien.boutin@chu-poitiers.fr
Facility Information:
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOUTIN Damien, MD

12. IPD Sharing Statement

Learn more about this trial

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

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