Clinical trial • Phase IV • Other

Lidocaine hydrochloride for Acute postoperative pain following breast surgery

Phase IV trial of Lidocaine hydrochloride for Acute postoperative pain following breast surgery. 128 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Acute postoperative pain following breast surgery
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-02-2025
First CTIS Authorization Date
11-02-2025

Trial design

Phase IV trial in Spain.

Target Sample Size
128
Trial Duration For Participant
2

Eligibility

Recruits 128 No vulnerable populations selected. Study population restricted to adult women (>18 years). Informed consent required (participants must have signed the informed consent). No assent or paediatric consent procedures described..

Vulnerable Population
No vulnerable populations selected. Study population restricted to adult women (>18 years). Informed consent required (participants must have signed the informed consent). No assent or paediatric consent procedures described.

Inclusion criteria

  • {"criterion_text":"-Mujer mayor de 18 años, diagnosticada de neoplasia maligna de mama, candidata a tratamiento quirúrgico programado en nuestro centro, Consorci Sanitari Integral, y que hayan firmado el consentimiento informado"}

Exclusion criteria

  • {"criterion_text":"-Alergia al anestésico local lidocaína"}
  • {"criterion_text":"-Antecedente de cirugía mamaria, torácica o de extremidad superior"}
  • {"criterion_text":"-Cirugía de recidiva del cáncer de mama"}
  • {"criterion_text":"-Dolor preoperatorio de la zona a intervenir"}
  • {"criterion_text":"-Alteración neurológica previa de la pared torácica"}
  • {"criterion_text":"-Antecedente de accidente cerebrovascular con afectación de la extremidad superior ipsilateral a la cirugía"}
  • {"criterion_text":"-Dificultad idiomática"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Dolor agudo postoperatorio a la 1, 4, 12, 24 y 48h postoperatorias (escala EVA), en reposo y en movimiento con la abducción del brazo > 90º","definition_or_measurement_approach":"Measured using the EVA (visual analogue scale) at 1, 4, 12, 24 and 48 hours postoperatively, assessed at rest and on movement (with arm abduction > 90°)."}

Recruitment

Planned Sample Size
128
Recruitment Window Months
48
Consent Approach
Informed consent required and must be signed by the participant. Subject information and informed consent form document is provided (HIP+CI_Version 3...). No assent procedures; adult participants provide consent themselves.

Methods

  • Recruitment of women scheduled for planned breast cancer surgery at the sponsor centre (Consorci Sanitari Integral / Hospital General Hospitalet); patients identified via hospital surgical pathway and approached at the treating centre.

Geography

Total Number Of Sites
1
Total Number Of Participants
128

Spain

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
11-02-2025
Number Of Sites
1
Number Of Participants
128

Sites

Site Name
Hospital General Hospitalet
Department Name
Ginecologia
Principal Investigator Name
puri regueiro
Principal Investigator Email
puri.regueiro@sanitatintegral.org
Contact Person Name
puri regueiro
Number Of Participants
128

Sponsor

Primary sponsor

Full Name
Consorci Sanitari Integral
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Lidoject 1 % Injektionslösung
Active Substance
Lidocaine hydrochloride
Modality
Small molecule
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised (marketing authorisation listed for Germany)
Maximum Dose
20 ml (max total dose amount 20 ml; max daily dose amount 20 ml)

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