Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy - Full Text View

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:

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

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 (Adult)
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

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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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Kaplan B, Moy RL. Comparison of room temperature and warmed local anesthetic solution for tumescent liposuction. A randomized double-blind study. Dermatol Surg. 1996 Aug;22(8):707-9.

Yang CH, Hsu HC, Shen SC, Juan WH, Hong HS, Chen CH. Warm and neutral tumescent anesthetic solutions are essential factors for a less painful injection. Dermatol Surg. 2006 Sep;32(9):1119-22; discussion 1123.

Rubin JP, Bierman C, Rosow CE, Arthur GR, Chang Y, Courtiss EH, May JW Jr. The tumescent technique: the effect of high tissue pressure and dilute epinephrine on absorption of lidocaine. Plast Reconstr Surg. 1999 Mar;103(3):990-6; discussion 997-1002.

Rubin JP, Xie Z, Davidson C, Rosow CE, Chang Y, May JW Jr. Rapid absorption of tumescent lidocaine above the clavicles: a prospective clinical study. Plast Reconstr Surg. 2005 May;115(6):1744-51.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Danilla S, Fontbona M, de Valdés VD, Dagnino B, Sorolla JP, Israel G, Searle S, Norambuena H, Cabello R. Analgesic efficacy of lidocaine for suction-assisted lipectomy with tumescent technique under general anesthesia: a randomized, double-masked, controlled trial. Plast Reconstr Surg. 2013 Aug;132(2):327-32. doi: 10.1097/PRS.0b013e3182958b20.


Responsible Party:	Stefan Danilla, MD, MSc, Hospital Militar de Santiago
ClinicalTrials.gov Identifier:	NCT00591487 History of Changes
Other Study ID Numbers:	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 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

ClinicalTrials.gov processed this record on September 28, 2016