Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

Phase 3

• Conditions: Healthy
• Interventions: Drug: Lidocaine

• Registration Number: NCT00591487
• Lead Sponsor: Hospital Militar de Santiago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-12
• Study Start: 2007-12
• Study First Submitted: 2007-12-31
• Study First Submitted QC: 2008-01-10
• Last Update Submitted: 2008-01-10
• Study First Posted: 2008-01-11
• Last Update Posted: 2008-01-11
• Primary Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	Lidocaine	Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine
II	Lidocaine	Infiltration with 0.9% saline+1:1,000,000 epinephrine

Primary Outcome Measures

Name	Time	Method
Pain (VSA)	1, 6, 12, 18 and 24 post operative hours

Secondary Outcome Measures

Name	Time	Method
Rescue medication	1, 6, 12, 15 and 24 hours postoperative
Nausea, emesis, arrythmia, seizures, arrest, shock, death.	24 hours postoperative

Trial Locations

Locations (1)

Hospital Militar de Santiago; 🇨🇱 Santiago, RM, Chile