Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Healthy Clinical Trial

Official title:

Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00591487
• Other study ID #: HMS-LIPO-001
• Secondary ID: HMS-LIPO-001
• Status: Unknown status
• Phase: Phase 3
• First received: December 31, 2007
• Last updated: January 10, 2008
• Start date: December 2007

Study information

• Verified date: December 2007
• Source: Hospital Militar de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Militar de Santiago	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Militar de Santiago

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VSA)		1, 6, 12, 18 and 24 post operative hours
Secondary	Rescue medication		1, 6, 12, 15 and 24 hours postoperative
Secondary	Nausea, emesis, arrythmia, seizures, arrest, shock, death.		24 hours postoperative

External Links

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