HealthyPhase 3NCT00591487
Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy
A Phase 3 study testing Lidocaine in people with Healthy, run by Hospital Militar de Santiago at 1 site in Chile.
Trial summary
RCT of S/E of lidocaine infiltration in tumescent technique. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine Receives: Drug: Lidocaine |
| II | Placebo comparator | Infiltration with 0.9% saline+1:1,000,000 epinephrine Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VSA)
Measured: 1, 6, 12, 18 and 24 post operative hours
Secondary outcomes (2)
Rescue medication
Measured: 1, 6, 12, 15 and 24 hours postoperative
Nausea, emesis, arrythmia, seizures, arrest, shock, death.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Militar de Santiago
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Danilla, MD, MSc, Principal investigator, Hospital Militar de SantiagoGuillermo Israel, MD, Study chair, Hospital Militar de SantiagoMontserrat Fontbona, MD, Study chair, Hospital Militar de SantiagoRodrigo Cabello, MD, Study director, Hospital Militar de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591487
- Sponsor's protocol ID
- HMS-LIPO-001
- Other IDs
- HMS-LIPO-001
- Status last verified
- Dec 2007
- First submitted
- 31 Dec 2007
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
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 8780763Yang 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 16970691Rubin 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 10077095Rubin 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 15861085Danilla 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy With Tumescent Technique. A Randomized, Double Blinded, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00591487
- Acronym / sponsor ID
- HMS-LIPO-001
- Conditions
- Healthy
- Keywords
- suction, assisted, lipectomy, liposuction, contour, cosmetic, plastic, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Militar de SantiagoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (estimated)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT of S/E of lidocaine infiltration in tumescent technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: LidocaineInfiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine |
| II | Placebo comparator | Drug: LidocaineInfiltration with 0.9% saline+1:1,000,000 epinephrine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineSubcutaneous 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. | Drug | I, II |
Primary outcome
Pain (VSA)
Time frame: 1, 6, 12, 18 and 24 post operative hours
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2008.
- Background: PubMed 8780763Kaplan 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.
- Background: PubMed 16970691Yang 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.
- Background: PubMed 10077095Rubin 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.
- Background: PubMed 15861085Rubin 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.
- Derived from this study: PubMed 23897332Danilla 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine in people with Healthy, run by Hospital Militar de Santiago at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VSA) (time frame: 1, 6, 12, 18 and 24 post operative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00591487, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2008.