Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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I

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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.

II

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

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

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.

Interventions

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Lidocaine

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes