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Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

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ClinicalTrials.gov Identifier: NCT00591487
Recruitment Status : Unknown
Verified December 2007 by Hospital Militar de Santiago.
Recruitment status was:  Enrolling by invitation
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
Sponsor:
Information provided by:
Hospital Militar de Santiago

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Lidocaine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.
Study Start Date : December 2007
Estimated Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: I
Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine
Drug: 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.
Placebo Comparator: II
Infiltration with 0.9% saline+1:1,000,000 epinephrine
Drug: 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.



Primary Outcome Measures :
  1. Pain (VSA) [ Time Frame: 1, 6, 12, 18 and 24 post operative hours ]

Secondary Outcome Measures :
  1. Rescue medication [ Time Frame: 1, 6, 12, 15 and 24 hours postoperative ]
  2. Nausea, emesis, arrythmia, seizures, arrest, shock, death. [ Time Frame: 24 hours postoperative ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591487


Locations
Chile
Hospital Militar de Santiago
Santiago, RM, Chile
Sponsors and Collaborators
Hospital Militar de Santiago
Investigators
Principal Investigator: Stefan Danilla, MD, MSc Hospital Militar de Santiago
Study Chair: Guillermo Israel, MD Hospital Militar de Santiago
Study Chair: Montserrat Fontbona, MD Hospital Militar de Santiago
Study Director: Rodrigo Cabello, MD Hospital Militar de Santiago

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Danilla, MD, MSc, Hospital Militar de Santiago
ClinicalTrials.gov Identifier: NCT00591487     History of Changes
Other Study ID Numbers: HMS-LIPO-001
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: December 2007

Keywords provided by Hospital Militar de Santiago:
suction
assisted
lipectomy
liposuction
contour
cosmetic
plastic
surgery
Klein
tumescent
technique
Healthy women wanting Suction Assisted Lipectomy

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action