Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Hospital Militar de Santiago

Status and phase: Unknown; Phase 3

Conditions: Healthy

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00591487

HMS-LIPO-001

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

I

Active Comparator group

Description:

Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine

Treatment:

Drug: Lidocaine

II

Placebo Comparator group

Description:

Infiltration with 0.9% saline+1:1,000,000 epinephrine

Treatment:

Drug: Lidocaine