Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Study Description

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Brief Summary:

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

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

Study Design

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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

Arms and Interventions

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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.

Outcome Measures

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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 ]

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

Related Info 

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
First Posted:	January 11, 2008
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