PainPhase 4NCT02465008
Analgesic Effect of Levobupivacaine in Breast Augmentation
A Phase 4 study testing Levobupivacaine in people with Pain, run by General University Hospital of Valencia.
Trial summary
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women> 18 and <= 65 years
- Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
- ASA I and II
- Informed consent signed
Who cannot join
- Rejection of the patient
- ASA III or higher
- Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness).
- Allergy to NSAIDs, local anesthetics and / or morphine
- Patients treated for chronic pain
- Placement of drains for surgical needs
About this study
Official title: Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation
Read the detailed description
One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.
- Conditions
- Pain
- Being tested
- Levobupivacaine, Placebo
- Keywords
- postoperative, Patient-reported
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| levobupivaciane group | Experimental | Levobupivacaine group (L- bupivacaine 0,25% -2,5 mg/ml-) 60 ml. Total dosis in topical use 150 mg (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). Receives: Drug: Levobupivacaine |
| Placebo Comparator (saline solution) | Placebo comparator | Placebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).
Measured: at 6 hours the early postoperative period (after the end of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: Not recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Severiano Marin Bertoli, General University Hospital of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465008
- Sponsor's protocol ID
- PERPRO2014_V2
- Status last verified
- Jul 2016
- First submitted
- 3 Jun 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Levobupivacaine Administration in Periprosthetic Breast Augmentation With Implants
- ClinicalTrials.gov ID
- NCT02465008
- Acronym / sponsor ID
- PERPRO2014_V2
- Conditions
- Pain
- Keywords
- postoperative, Patient-reported
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- General University Hospital of ValenciaUniversity, hospital or other
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 8 Jun 2015 (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.
The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation
Detailed description
One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levobupivaciane group | Experimental | Drug: LevobupivacaineLevobupivacaine group (L- bupivacaine 0,25% -2,5 mg/ml-) 60 ml. Total dosis in topical use 150 mg (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). |
| Placebo Comparator (saline solution) | Placebo comparator | Drug: PlaceboPlacebo group (saline solution) 60 ml (administered irrigation 30 ml into the surgical pocket bilaterally intraoperatively). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women> 18 and <= 65 years
- Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
- ASA I and II
- Informed consent signed
Key exclusion criteria (6 listed)
- Rejection of the patient
- ASA III or higher
- Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness).
- Allergy to NSAIDs, local anesthetics and / or morphine
- Patients treated for chronic pain
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 |
|---|---|---|
| Levobupivacaine | Drug | levobupivaciane group |
| Placebo | Drug | Placebo Comparator (saline solution) |
Primary outcome
Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough).
Time frame: at 6 hours the early postoperative period (after the end of anesthesia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Pain, run by General University Hospital of Valencia.
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 6 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: paused, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS) at rest and movement (cough). (time frame: at 6 hours the early postoperative period (after the end of anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.