LIDOCAINE IN ISCHEMIA-REPERFUSION INJURY FROM MICROSURGICAL BREAST RECONSTRUCTION.

LIDOCAINE IN ISCHEMIA-REPERFUSION INJURY FROM MICROSURGICAL BREAST RECONSTRUCTION. RANDOMISED UNICENTRIC, DOUBLE-BLIND, CLINICAL, CONTROLLED TRIAL.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000623-73-ES

Enrollment

Unknown

Registered

2016-07-15

Start date

2016-09-29

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia-reperfusion injury from breast reconstruction microsurgical flaps.

Interventions

Trade Name: Lidocaína B. Braun Product Name: Lidocaína B. Braun Product Code: Lidocaína B. Braun Pharmaceutical Form: Solution for injection INN or Proposed INN: LIDOCAINE Other descriptive name: LIDO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women between 18 and 70 years old including both ends, at the time of signing the informed consent, which are going to be operated on microsurgical breast reconstruction with DIEP flap abdominal type. Written informed consent in accordance with ICH / GCP and to the Spanish legislation, obtained before any study procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Pregnancy and lactation. - Have received prior radiation therapy. - Being a smoker. - Hypersensitivity or allergy to lidocaine and / or amide type local anesthetics, or any of its components. - Liver disease, heart disease or diabetic. - Patients who had received any investigational drug within 60 days prior to study drug administration. - Inability to give informed consent. - If there are findings on physical examination in the investigator's opinion, anomalies in the results of laboratory tests or other medical, social or psychosocial factors that could negatively influence

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of lidocaine in the decrease of ischemic-reperfusion injury from breast microsurgical reconstruction, based on the MDA plasma levels at 12 hours after reperfusion.;Secondary Objective: 1. To evaluate plasma levels of MDA at 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients. 2. To evaluate SOD serum at 12 and 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients. 3.To evaluate the percentage of surface flap necrosis in patients who received lidocaine compared with untreated patients trhough clinical assessment in Plastic Surgery medical appoinments at 7, 14 and 30 days after reperfusion.;Primary end point(s): MDA plasma levels at 12 hours after reperfusion;Timepoint(s) of evaluation of this end point: 12 hours after reperfusion.	—

Measure

Time frame

Main Objective: To evaluate the effect of lidocaine in the decrease of ischemic-reperfusion injury from breast microsurgical reconstruction, based on the MDA plasma levels at 12 hours after reperfusion.;Secondary Objective: 1. To evaluate plasma levels of MDA at 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients. 2. To evaluate SOD serum at 12 and 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients. 3.To evaluate the percentage of surface flap necrosis in patients who received lidocaine compared with untreated patients trhough clinical assessment in Plastic Surgery medical appoinments at 7, 14 and 30 days after reperfusion.;Primary end point(s): MDA plasma levels at 12 hours after reperfusion;Timepoint(s) of evaluation of this end point: 12 hours after reperfusion.

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Secondary

Measure	Time frame
Secondary end point(s): MDA plasma levels 24 hours after reperfusion. SOD serum levels 12 hours after reperfusion. SOD serum levels 24 hours after reperfusion. Partial surface or total flap fat necrosis, according to clinical criteria based on the measurement area to total necrosis of the flap. This standard will bemeasured by photography and paper overlay grid.;Timepoint(s) of evaluation of this end point: 12 and 24 hours after reperfusion. 7,14,30 days after reperfusion.	—

Measure

Time frame

Secondary end point(s): MDA plasma levels 24 hours after reperfusion. SOD serum levels 12 hours after reperfusion. SOD serum levels 24 hours after reperfusion. Partial surface or total flap fat necrosis, according to clinical criteria based on the measurement area to total necrosis of the flap. This standard will bemeasured by photography and paper overlay grid.;Timepoint(s) of evaluation of this end point: 12 and 24 hours after reperfusion. 7,14,30 days after reperfusion.

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Countries

Spain

Contacts

Public ContactFarmacología clínica

FUNDACIÓN INVESTIGACIÓN BIOMÉDICA HOSPITAL PUERTA DE HIERRO

farmacologia_clinica@idiphim.org+34911916481

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026