Arm PainPhase 4NCT06865911
Cold Versus Warm Tumescent Solution in Arm Liposculpture
A Phase 4 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's, Warm saline and Liposuction of the arms in people with Arm Pain and Arm Aesthetics, run by Eternal Beauty SAS at 1 site in Colombia.
Trial summary
The goal of this clinical trial is to evaluate whether the temperature of tumescent solution (cold vs. warm) affects postoperative outcomes in adults undergoing arm liposculpture. The study includes men and women aged 18-60 years with certain body complexity, however no obese patients are allowed to enter the study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arm Pain, Arm Aesthetics, Liposuction
- What is being tested?
- Cold crystalloid infusions, 0.9%NaCl or Ringer's, Warm saline and Liposuction of the arms
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2023to 30 Jun 2024
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Body mass index between 18 and 30.
- Patients scheduled for bilateral arm liposculpture together with other body contouring procedures.
- Able to provide informed consent.
Who cannot join
- History of coagulopathies.
- ASA > II.
- Allergies to tumescent solution components (epinephrine, lidocaine).
- Pregnant or lactating individuals.
- Previous surgeries on the arms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Versus Warm Tumescent Solution in Arm Liposculpture: A Double-blind Clinical Study.
The goal of this clinical trial is to evaluate whether the temperature of tumescent solution (cold vs. warm) affects postoperative outcomes in adults undergoing arm liposculpture. The study includes men and women aged 18-60 years with certain body complexity, however no obese patients are allowed to enter the study. All patients are undergoing bilateral arm liposculpture as part of body contouring procedures.
The main questions it aims to answer are:
Read more
- Does using a cold tumescent solution reduce postoperative bruising compared to a warm solution?
- Does a cold tumescent solution reduce postoperative inflammation compared to a warm solution?
- How does solution temperature affect the quality of fat samples collected during liposuction?
Researchers will compare the cold tumescent solution group to the warm tumescent solution group to determine whether a lower temperature provides benefits in terms of reduced bruising, inflammation, and improved fat quality.
Participants will:
- Receive either a cold (4°C) or warm (room temperature) tumescent solution in each arm before liposuction.
- Undergo fat emulsification with VASER technology.
- Have one arm treated with Power-Assisted Liposuction (PAL) and the other with Conventional Suction-Assisted Liposuction (SAL).
- Have liposuction fat samples collected for analysis of fat content, blood content, and overall fat quality.
- Be monitored for bruising and inflammation on Days 1, 3, and 7 using an image analyzing software and arm circumference measurements.
- Complete a satisfaction survey 30 days after surgery.
Safety considerations include monitoring core temperature and using external warming devices if needed to prevent hypothermia.
Read the detailed description
Study Objective:
To compare the effects of cold (4°C) and warm tumescent solutions in arm liposculpture on postoperative outcomes, specifically in terms of inflammation, bruising, and fat emulsification using different liposuction techniques.
Study Design
- Type: Interventional (Clinical Trial)
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double-blind (Participants and Surgeon)
- Primary Purpose: Prevention of complications
Population: Adults aged 18-60 years scheduled for bilateral arm liposculpture together with other body contouring procedures.
Interventions
- Cold Tumescent Solution Group (Intervention arm)
- Infiltration of tumescent solution at 4°C.
- Warm Tumescent Solution Group (Control arm) o Infiltration of standard tumescent solution (room temperature).
Tumescent Solution Composition (for both groups):
- 7 cc of 2% Lidocaine without Epinephrine.
- 1 mg of Epinephrine.
- 250 mg of Tranexamic Acid.
Procedure Outline
- Infiltration Phase: Each arm is infiltrated with its respective tumescent solution (cold or warm). Allow a 15-minute diffusion period for the tumescent solution to take effect.
- VASER Emulsification: Apply VASER technology to both arms at 50% power for fat emulsification.
- Liposuction Techniques: Arm A: Liposculpture performed using Power-Assisted Liposuction (PAL). Arm B: Liposculpture performed using Conventional Suction-Assisted Liposuction (SAL).
- Fat is collected separately for each arm and stored in individual containers.
- Sample Collection for Analysis:
- Collect a lipocrit sample in a 10 ml syringe from each arm.
- Send the samples to pathology for analysis of fat content, blood content, and overall quality of the liposuction sample.
Primary Outcome Measures
- Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
- Inflammation: Measured via arm circumference on Days 1, 3, and 7.
- Quality of Fat Samples: Pathological evaluation of fat and blood content from the lipocrit samples.
Secondary Outcome Measures
- Patient Satisfaction: Surveys conducted 30 days post-procedure.
- Complication Rates: Hematoma, seroma, and infection rates evaluated within 30 days post-op.
Safety Considerations:
Surgeons must be cautious when using cold tumescent solutions due to the risk of hypothermia, particularly during extended procedures. Continuous core temperature monitoring and the use of external warming devices are recommended to mitigate the risks of lowering core temperature.
Timeline:
- Start Date: January 2023
- Primary Completion Date: December 2023
- Study Completion Date: June 2024
- Conditions
- Arm Pain, Arm Aesthetics, Liposuction, Safety of Intervention
- Being tested
- Cold crystalloid infusions, 0.9%NaCl or Ringer's, Warm saline, Liposuction of the arms
- Keywords
- Tumescent solution, Arm liposculpture, Cold anesthesia, VASER-assisted lipoplasty, Liposuction outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold crystalloid infusions, 0.9%NaCl or Ringer'sOther
Also called Tumescent solution
Infiltration of cold tumescent solution at 4 C for lipoplasty.
Warm salineOther
Also called Warm tumescent solution
Infiltration of warm tumescent solution at body temperature for lipoplasty.
Liposuction of the armsProcedure or surgery
Infiltration of tumescent solution in both arms, VASER fat emulsification then power-assisted liposuction of the arms.
| Study group | Role | What they receive |
|---|---|---|
| Cold tumescent solution | Experimental | 1. Cold Tumescent Solution Group: Infiltration of tumescent solution at 4°C. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid. Receives: Other: Cold crystalloid infusions, 0.9%NaCl or Ringer's; Procedure: Liposuction of the arms |
| Warm tumescent solution | Placebo comparator | 2. Warm Tumescent Solution Group: Infiltration of tumescent solution at room temperature. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid. Receives: Other: Warm saline; Procedure: Liposuction of the arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecchymosis
- Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
Measured: 7 days
Edema/inflammation
- Inflammation: Measured via arm circumference on Days 1, 3, and 7.
Measured: 7 days
Pain score
- Postoperative pain: Scoring system using the visual analogue scale. From 1 to 10 at each time point: immediately after surgery, 1 ,3 and 7 days postoperative.
Measured: 7 days
Secondary outcomes (2)
Lipocrit evaluation
- Quality of Fat Samples: Pathological evaluation of fat and blood content from the lipocrit samples.
Measured: 6 hours
Patient satisfaction
- Patient Satisfaction: Surveys conducted 30 days post-procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start12 Jan 2023
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
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 Arm PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prevention of excessive edema, pain and ecchymosis after liposculpture with the use of cold tumescent solution.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eternal Beauty SAS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Cristina Cala Uribe, Eternal Beauty SAS
- Investigators
- Mauricio E Perez Pachon, MD, Study director, Total Definer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865911
- Sponsor's protocol ID
- CP_ArmCOLD001
- Other IDs
- Cold Arms
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is patient information that cannot be disclosed due to patient preferences.
Publications
Hoyos AE, Perez Pachon ME, Benavides JE, Eljaiek A, Borras Osorio M, Ramirez B. Effects of Optimal Temperature Control in Body Contouring Surgery: A Nonrandomized Controlled Clinical Trial. Aesthet Surg J. 2024 Oct 15;44(11):NP790-NP797. doi: 10.1093/asj/sjae142.
PubMed 38953184Hoyos A, Perez M. Arm dynamic definition by liposculpture and fat grafting. Aesthet Surg J. 2012 Nov;32(8):974-87. doi: 10.1177/1090820X12461498.
PubMed 23110928Cala Uribe LC, Perez Pachon ME, Babaitis R, Zannin Ferrero A, Aljure Diaz MF. Variable Energy and Ultrasound-based Liposculpture of the Arms: Multicenter and Multidevice Study. Plast Reconstr Surg Glob Open. 2024 Mar 19;12(3):e5649. doi: 10.1097/GOX.0000000000005649. eCollection 2024 Mar.
PubMed 38948160Cala Uribe LC, Perez Pachon ME, Zannin Ferrero A, Neri Morales C, Silva Gutierrez J, Manrique Cruz AD, Maza MF, Acero Mondragon EJ, Celis Regalado LG. Effects of Bipolar Radiofrequency on Collagen Synthesis from Patients with Brachial Ptosis. Plast Reconstr Surg Glob Open. 2023 Apr 13;11(4):e4924. doi: 10.1097/GOX.0000000000004924. eCollection 2023 Apr.
PubMed 37063507Cala Uribe LC, Perez Pachon ME, Zannin Ferrero A. Cold versus Warm Tumescent Solution in Arm Liposculpture: A Double-Blind Randomized Clinical Study. Plast Reconstr Surg. 2026 Sep 1;158(3S):30S-37S. doi: 10.1097/PRS.0000000000012595. Epub 2026 Aug 26.
PubMed 41211968
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Versus Warm Tumescent Solution in Arm Liposculpture: A Double-blind Clinical Study.
- ClinicalTrials.gov ID
- NCT06865911
- Acronym / sponsor ID
- CP_ArmCOLD001
- Conditions
- Arm Pain, Arm Aesthetics, Liposuction, Safety of Intervention
- Keywords
- Tumescent solution, Arm liposculpture, Cold anesthesia, VASER-assisted lipoplasty, Liposuction outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eternal Beauty SASUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Mar 2025 (actual)
- 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.
The goal of this clinical trial is to evaluate whether the temperature of tumescent solution (cold vs. warm) affects postoperative outcomes in adults undergoing arm liposculpture. The study includes men and women aged 18-60 years with certain body complexity, however no obese patients are allowed to enter the study. All patients are undergoing bilateral arm liposculpture as part of body contouring procedures.
The main questions it aims to answer are:
- Does using a cold tumescent solution reduce postoperative bruising compared to a warm solution?
- Does a cold tumescent solution reduce postoperative inflammation compared to a warm solution?
- How does solution temperature affect the quality of fat samples collected during liposuction?
Researchers will compare the cold tumescent solution group to the warm tumescent solution group to determine whether a lower temperature provides benefits in terms of reduced bruising, inflammation, and improved fat quality.
Participants will:
- Receive either a cold (4°C) or warm (room temperature) tumescent solution in each arm before liposuction.
- Undergo fat emulsification with VASER technology.
- Have one arm treated with Power-Assisted Liposuction (PAL) and the other with Conventional Suction-Assisted Liposuction (SAL).
- Have liposuction fat samples collected for analysis of fat content, blood content, and overall fat quality.
- Be monitored for bruising and inflammation on Days 1, 3, and 7 using an image analyzing software and arm circumference measurements.
- Complete a satisfaction survey 30 days after surgery.
Safety considerations include monitoring core temperature and using external warming devices if needed to prevent hypothermia.
Detailed description
Study Objective:
To compare the effects of cold (4°C) and warm tumescent solutions in arm liposculpture on postoperative outcomes, specifically in terms of inflammation, bruising, and fat emulsification using different liposuction techniques.
Study Design
- Type: Interventional (Clinical Trial)
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double-blind (Participants and Surgeon)
- Primary Purpose: Prevention of complications
Population: Adults aged 18-60 years scheduled for bilateral arm liposculpture together with other body contouring procedures.
Interventions
- Cold Tumescent Solution Group (Intervention arm)
- Infiltration of tumescent solution at 4°C.
- Warm Tumescent Solution Group (Control arm) o Infiltration of standard tumescent solution (room temperature).
Tumescent Solution Composition (for both groups):
- 7 cc of 2% Lidocaine without Epinephrine.
- 1 mg of Epinephrine.
- 250 mg of Tranexamic Acid.
Procedure Outline
- Infiltration Phase: Each arm is infiltrated with its respective tumescent solution (cold or warm). Allow a 15-minute diffusion period for the tumescent solution to take effect.
- VASER Emulsification: Apply VASER technology to both arms at 50% power for fat emulsification.
- Liposuction Techniques: Arm A: Liposculpture performed using Power-Assisted Liposuction (PAL). Arm B: Liposculpture performed using Conventional Suction-Assisted Liposuction (SAL).
- Fat is collected separately for each arm and stored in individual containers.
- Sample Collection for Analysis:
- Collect a lipocrit sample in a 10 ml syringe from each arm.
- Send the samples to pathology for analysis of fat content, blood content, and overall quality of the liposuction sample.
Primary Outcome Measures
- Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
- Inflammation: Measured via arm circumference on Days 1, 3, and 7.
- Quality of Fat Samples: Pathological evaluation of fat and blood content from the lipocrit samples.
Secondary Outcome Measures
- Patient Satisfaction: Surveys conducted 30 days post-procedure.
- Complication Rates: Hematoma, seroma, and infection rates evaluated within 30 days post-op.
Safety Considerations:
Surgeons must be cautious when using cold tumescent solutions due to the risk of hypothermia, particularly during extended procedures. Continuous core temperature monitoring and the use of external warming devices are recommended to mitigate the risks of lowering core temperature.
Timeline:
- Start Date: January 2023
- Primary Completion Date: December 2023
- Study Completion Date: June 2024
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prevention of excessive edema, pain and ecchymosis after liposculpture with the use of cold tumescent solution.
| Arm | Type | Receives |
|---|---|---|
| Cold tumescent solution | Experimental | Other: Cold crystalloid infusions, 0.9%NaCl or Ringer's, Procedure: Liposuction of the arms1. Cold Tumescent Solution Group: Infiltration of tumescent solution at 4°C. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid. |
| Warm tumescent solution | Placebo comparator | Other: Warm saline, Procedure: Liposuction of the arms2. Warm Tumescent Solution Group: Infiltration of tumescent solution at room temperature. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years.
- Body mass index between 18 and 30.
- Patients scheduled for bilateral arm liposculpture together with other body contouring procedures.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- History of coagulopathies.
- ASA > II.
- Allergies to tumescent solution components (epinephrine, lidocaine).
- Pregnant or lactating individuals.
- Previous surgeries on the arms.
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 |
|---|---|---|
| Cold crystalloid infusions, 0.9%NaCl or Ringer'sAlso: Tumescent solutionInfiltration of cold tumescent solution at 4 C for lipoplasty. | Other | Cold tumescent solution |
| Warm salineAlso: Warm tumescent solutionInfiltration of warm tumescent solution at body temperature for lipoplasty. | Other | Warm tumescent solution |
| Liposuction of the armsInfiltration of tumescent solution in both arms, VASER fat emulsification then power-assisted liposuction of the arms. | Procedure or surgery | Cold tumescent solution, Warm tumescent solution |
Primary outcome
Ecchymosis
Time frame: 7 days
1. Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
Edema/inflammation
Time frame: 7 days
2. Inflammation: Measured via arm circumference on Days 1, 3, and 7.
Pain score
Time frame: 7 days
3. Postoperative pain: Scoring system using the visual analogue scale. From 1 to 10 at each time point: immediately after surgery, 1 ,3 and 7 days postoperative.
2 secondary outcomes
Lipocrit evaluation
Time frame: 6 hours
Patient satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 38953184Hoyos AE, Perez Pachon ME, Benavides JE, Eljaiek A, Borras Osorio M, Ramirez B. Effects of Optimal Temperature Control in Body Contouring Surgery: A Nonrandomized Controlled Clinical Trial. Aesthet Surg J. 2024 Oct 15;44(11):NP790-NP797. doi: 10.1093/asj/sjae142.
- Background: PubMed 23110928Hoyos A, Perez M. Arm dynamic definition by liposculpture and fat grafting. Aesthet Surg J. 2012 Nov;32(8):974-87. doi: 10.1177/1090820X12461498.
- Background: PubMed 38948160Cala Uribe LC, Perez Pachon ME, Babaitis R, Zannin Ferrero A, Aljure Diaz MF. Variable Energy and Ultrasound-based Liposculpture of the Arms: Multicenter and Multidevice Study. Plast Reconstr Surg Glob Open. 2024 Mar 19;12(3):e5649. doi: 10.1097/GOX.0000000000005649. eCollection 2024 Mar.
- Background: PubMed 37063507Cala Uribe LC, Perez Pachon ME, Zannin Ferrero A, Neri Morales C, Silva Gutierrez J, Manrique Cruz AD, Maza MF, Acero Mondragon EJ, Celis Regalado LG. Effects of Bipolar Radiofrequency on Collagen Synthesis from Patients with Brachial Ptosis. Plast Reconstr Surg Glob Open. 2023 Apr 13;11(4):e4924. doi: 10.1097/GOX.0000000000004924. eCollection 2023 Apr.
- Derived from this study: PubMed 41211968Cala Uribe LC, Perez Pachon ME, Zannin Ferrero A. Cold versus Warm Tumescent Solution in Arm Liposculpture: A Double-Blind Randomized Clinical Study. Plast Reconstr Surg. 2026 Sep 1;158(3S):30S-37S. doi: 10.1097/PRS.0000000000012595. Epub 2026 Aug 26.
- Individual participant dataSharing planned: No. There is patient information that cannot be disclosed due to patient preferences.
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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.
Mauricio E Perez Pachon, MD study director
Total Definer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's, Warm saline and Liposuction of the arms in people with Arm Pain and Arm Aesthetics, run by Eternal Beauty SAS at 1 site in Colombia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 2025. 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 Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ecchymosis (time frame: 7 days). The study lists 3 primary outcomes in all. 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 NCT06865911, 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 Mar 2025.