Status unknownNCT00591487Updated Jan 11, 2008

Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

A Phase 3 interventional study of Lidocaine in Healthy, sponsored by Hospital Militar de Santiago. Status unknown at 1 site in Chile. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-11.

Sponsored by Hospital Militar de Santiago · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2007), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study summary

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

Conditions studied

Healthy

Keywords

suction
assisted
lipectomy
liposuction
contour
cosmetic
plastic
surgery
Klein
tumescent
technique
Healthy women wanting Suction Assisted Lipectomy

In context

Lead sponsor

This is the only study on the registry with Hospital Militar de Santiago as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Care provider)
Enrollment: 60 participants (estimated)

Study arms

Active comparator
I
Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine
Drug: Lidocaine
Placebo comparator
II
Infiltration with 0.9% saline+1:1,000,000 epinephrine
Drug: Lidocaine

Interventions

DrugLidocaine
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 researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Hospital Militar de Santiago
Santiago, RM, Chile

References and documents

Publications

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. PubMed 8780763 ↗
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. PubMed 16970691 ↗
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. PubMed 10077095 ↗
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. PubMed 15861085 ↗
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. PubMed 23897332 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00591487
Lead sponsor: Hospital Militar de Santiago
First posted: Jan 11, 2008
Start date: Dec 2007
Primary completion: Dec 2008 (estimated)
Last update: Jan 11, 2008

Study contacts

Stefan Danilla, MD, MSc

principal investigator · Hospital Militar de Santiago

Guillermo Israel, MD

study chair · Hospital Militar de Santiago

Montserrat Fontbona, MD

study chair · Hospital Militar de Santiago

Rodrigo Cabello, MD

study director · Hospital Militar de Santiago

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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