NCT00591487

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

January 11, 2008

Status Verified

December 1, 2007

Enrollment Period

1 year

First QC Date

December 31, 2007

Last Update Submit

January 10, 2008

Conditions

Healthy

Keywords

suctionassistedlipectomyliposuctioncontourcosmeticplasticsurgeryKleintumescenttechniqueHealthy women wanting Suction Assisted Lipectomy

Outcome Measures

Primary Outcomes (1)

  • Pain (VSA)

    1, 6, 12, 18 and 24 post operative hours

Secondary Outcomes (2)

  • Rescue medication

    1, 6, 12, 15 and 24 hours postoperative

  • Nausea, emesis, arrythmia, seizures, arrest, shock, death.

    24 hours postoperative

Study Arms (2)

I

ACTIVE COMPARATOR

Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine

Drug: Lidocaine

II

PLACEBO COMPARATOR

Infiltration with 0.9% saline+1:1,000,000 epinephrine

Drug: Lidocaine

Interventions

LidocaineDRUG

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.

III

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Militar de Santiago

Santiago, RM, Chile

Location

Related Publications (5)

  • 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.

    PMID: 8780763BACKGROUND

  • 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.

    PMID: 16970691BACKGROUND

  • 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.

    PMID: 10077095BACKGROUND

  • 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.

    PMID: 15861085BACKGROUND

  • 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.

    PMID: 23897332DERIVED

Related Links

MeSH Terms

Conditions

Helping Behavior

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Stefan Danilla, MD, MSc

    Hospital Militar de Santiago

    PRINCIPAL INVESTIGATOR

  • Guillermo Israel, MD

    Hospital Militar de Santiago

    STUDY CHAIR

  • Montserrat Fontbona, MD

    Hospital Militar de Santiago

    STUDY CHAIR

  • Rodrigo Cabello, MD

    Hospital Militar de Santiago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2008

Last Updated

January 11, 2008

Record last verified: 2007-12

Locations

CL(1)