Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Study Overview
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Brief Summary
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RCT of S/E of lidocaine infiltration in tumescent technique.

Official Title
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Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine | Drug: Lidocaine<br>* 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.<br>|
| Placebo Comparator: II<br>Infiltration with 0.9% saline+1:1,000,000 epinephrine | Drug: Lidocaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VSA) |  | 1, 6, 12, 18 and 24 post operative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue medication |  | 1, 6, 12, 15 and 24 hours postoperative | 
| Nausea, emesis, arrythmia, seizures, arrest, shock, death. |  | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suction, assisted, lipectomy, liposuction, contour, cosmetic, plastic, surgery, Klein, tumescent, technique, Healthy women wanting Suction Assisted Lipectomy