Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

January 10, 2008 updated by: Hospital Militar de Santiago

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile
        • Hospital Militar de Santiago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (VSA)
Time Frame: 1, 6, 12, 18 and 24 post operative hours
1, 6, 12, 18 and 24 post operative hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Rescue medication
Time Frame: 1, 6, 12, 15 and 24 hours postoperative
1, 6, 12, 15 and 24 hours postoperative
Nausea, emesis, arrythmia, seizures, arrest, shock, death.
Time Frame: 24 hours postoperative
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMS-LIPO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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