Clinical trial NCT00591487: Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy
Official title: Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy
Keywords: suction
assisted
lipectomy
liposuction
contour
cosmetic
plastic
surgery
Klein
tumescent
technique
Healthy women wanting Suction Assisted Lipectomy
Lead sponsor: Hospital Militar de Santiago
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Pain (VSA)
timeFrame: 1, 6, 12, 18 and 24 post operative hours
Secondary outcomes:
measure: Rescue medication
timeFrame: 1, 6, 12, 15 and 24 hours postoperative
measure: Nausea, emesis, arrythmia, seizures, arrest, shock, death.
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Militar de Santiago
state: RM
Study officials:
affiliation: Hospital Militar de Santiago
name: Stefan Danilla, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Militar de Santiago
name: Guillermo Israel, MD
role: STUDY_CHAIR
affiliation: Hospital Militar de Santiago
name: Montserrat Fontbona, MD
role: STUDY_CHAIR
affiliation: Hospital Militar de Santiago
name: Rodrigo Cabello, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1524-4725.1996.tb00621.x.
citation: 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. doi: 10.1111/j.1524-4725.2006.32254.x.
citation: 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.
citation: 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. doi: 10.1097/01.prs.0000161678.10555.53.
citation: Danilla S, Fontbona M, de Valdes 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):327-332. doi: 10.1097/PRS.0b013e3182958b20.