Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hospital Militar de Santiago
ClinicalTrials.gov Identifier:
NCT00591487
First received: December 31, 2007
Last updated: January 10, 2008
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lidocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Hospital Militar de Santiago:

Primary Outcome Measures:
  • Pain (VSA) [ Time Frame: 1, 6, 12, 18 and 24 post operative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rescue medication [ Time Frame: 1, 6, 12, 15 and 24 hours postoperative ] [ Designated as safety issue: No ]
  • Nausea, emesis, arrythmia, seizures, arrest, shock, death. [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Additional 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, HMS-LIPO-001
Study First Received: December 31, 2007
Last Updated: January 10, 2008
Health Authority: Chile: Instituto de Salud Pública de Chile

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014