Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Phase 3UnknownNCT00591487

Hospital Militar de Santiago60 enrolled

Overview

RCT of S/E of lidocaine infiltration in tumescent technique.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LidocaineDRUG

Subcutaneous infiltration with Active/Placebo solutions with tumescent technique previous to suction assisted lipectomy. Patient abdomen and back will be divided in 4 zones anterior and posterior, one side (left or right) will be infiltrated with active solution and the other with placebo. The allocation of the side will be made with random numbers.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Woman * I or II of the Classification of the American Society of Anesthesiologists. * Completed high school. * Between 18 and 40 years old * At least suction of entire abdomen and back * Body mass index between 20 and 27 * Accept written informed consent Exclusion Criteria: * Associated surgery * Hypersensibility to (Cefazolin or Clindamycin, Lidocaine, Ketorolac, Morphine, Remifentanyl, Propofol, Tramadol). * Pregnancy * Previous surgery to abdominal wall or back, including cesarean. * Abdominal wall hernia * Previous liposuction * Active psychosis

Locations (1)

Hospital Militar de Santiago

Santiago, RM, Chile

Outcomes

Primary Outcomes

Pain (VSA)

Time frame: 1, 6, 12, 18 and 24 post operative hours

Secondary Outcomes

Rescue medication

Time frame: 1, 6, 12, 15 and 24 hours postoperative

Nausea, emesis, arrythmia, seizures, arrest, shock, death.

Time frame: 24 hours postoperative

Data from ClinicalTrials.gov

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