Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 |
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.
|
- Pain (VSA) [ Time Frame: 1, 6, 12, 18 and 24 post operative hours ]
- Rescue medication [ Time Frame: 1, 6, 12, 15 and 24 hours postoperative ]
- Nausea, emesis, arrythmia, seizures, arrest, shock, death. [ Time Frame: 24 hours postoperative ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Chile | |
Hospital Militar de Santiago | |
Santiago, RM, Chile |
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 |