Local AnestheticPhase 4NCT01389934
Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
A Phase 4 study testing levo-bupicaine in people with Local Anesthetic, run by Basque Health Service at 1 site in Spain.
Trial summary
Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Local Anesthetic
- What is being tested?
- levo-bupicaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Jan 2012
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
- Sign informed consent.
Who cannot join
- Mastectomy without lymphadenectomy
- Over 80 years
- Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
- Severe liver or kidney disease
- Patients allergic or intolerant to any of the drugs used in the study protocol.
- Regular users of analgesics or narcotics
Trial locations and contacts
1 site in 1 country.
About this study
Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this study demonstrate the efficacy of administering a local anesthetic into the surgical bed of women operated radical mastectomy for breast cancer for the control of postoperative pain.
Material and methods: double-blind randomized clinical trial. The investigators recruited patients who underwent modified radical mastectomy that met inclusion and exclusion criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic and rescue medication was identical in both groups.
Statistical analysis: The baseline patient characteristics of the patients were analyzed by Chi square or Student t always meet criteria of normality, otherwise it will use the Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse events will be held on chi-square test.
- Conditions
- Local Anesthetic
- Being tested
- levo-bupicaine, Placebo
- Keywords
- levo-bupicaine, Radical, Mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levo-bupicaineDrug
Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention
PlaceboDrug
Women of this group be infused saline 2 ml / h for 48h.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Women of this group be infused saline 2 ml / h for 48h. Receives: Drug: Placebo |
| levo-bupicaine | Experimental | Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h. Receives: Drug: levo-bupicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of administering levo-bupicaine to control postoperative pain.
the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad)
Measured: 48 hours
Secondary outcomes (1)
Decreased consumption of other analgesics
We will measure the number of rescue doses of each drug (acetoaminphen, metamizol, dexketoprofen and morphine) We will include all minor adverse effects (nausea, vomiting ...) as severe (sedacion..) and their resolution.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Local AnestheticStudies 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, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389934
- Sponsor's protocol ID
- MASTEC-002
- Status last verified
- Jul 2011
- First submitted
- 5 Jul 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferreira Laso L, Lopez Picado A, Antonanzas Villar F, Lamata de la Orden L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Valero Martinez C, Aizpuru F, Hernandez Chaves R. Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy. Clin Drug Investig. 2015 Sep;35(9):575-82. doi: 10.1007/s40261-015-0316-4.
PubMed 26305021Ferreira Laso L, Lopez-Picado A, Lamata L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Antonanzas Villar F, Valero Martinez C, Aizpuru F, Hernanz Chaves R. Postoperative analgesia by infusion of local anesthetic into the surgical wound after modified radical mastectomy: a randomized clinical trial. Plast Reconstr Surg. 2014 Dec;134(6):862e-870e. doi: 10.1097/PRS.0000000000000762.
PubMed 25415108
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
- ClinicalTrials.gov ID
- NCT01389934
- Acronym / sponsor ID
- MASTEC-002
- Conditions
- Local Anesthetic
- Keywords
- levo-bupicaine, Radical, Mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2011 (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.
Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this study demonstrate the efficacy of administering a local anesthetic into the surgical bed of women operated radical mastectomy for breast cancer for the control of postoperative pain.
Material and methods: double-blind randomized clinical trial. The investigators recruited patients who underwent modified radical mastectomy that met inclusion and exclusion criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic and rescue medication was identical in both groups.
Statistical analysis: The baseline patient characteristics of the patients were analyzed by Chi square or Student t always meet criteria of normality, otherwise it will use the Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse events will be held on chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboWomen of this group be infused saline 2 ml / h for 48h. |
| levo-bupicaine | Experimental | Drug: levo-bupicaineWomen of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
- Sign informed consent.
Key exclusion criteria (6 listed)
- Mastectomy without lymphadenectomy
- Over 80 years
- Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
- Severe liver or kidney disease
- Patients allergic or intolerant to any of the drugs used in the study protocol.
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 |
|---|---|---|
| levo-bupicaineWomen of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention | Drug | levo-bupicaine |
| PlaceboWomen of this group be infused saline 2 ml / h for 48h. | Drug | Control |
Primary outcome
effectiveness of administering levo-bupicaine to control postoperative pain.
Time frame: 48 hours
the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad)
1 secondary outcome
Decreased consumption of other analgesics
Time frame: 48 hours
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 3 Feb 2012.
- Derived from this study: PubMed 26305021Ferreira Laso L, Lopez Picado A, Antonanzas Villar F, Lamata de la Orden L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Valero Martinez C, Aizpuru F, Hernandez Chaves R. Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy. Clin Drug Investig. 2015 Sep;35(9):575-82. doi: 10.1007/s40261-015-0316-4.
- Derived from this study: PubMed 25415108Ferreira Laso L, Lopez-Picado A, Lamata L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Antonanzas Villar F, Valero Martinez C, Aizpuru F, Hernanz Chaves R. Postoperative analgesia by infusion of local anesthetic into the surgical wound after modified radical mastectomy: a randomized clinical trial. Plast Reconstr Surg. 2014 Dec;134(6):862e-870e. doi: 10.1097/PRS.0000000000000762.
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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.
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 levo-bupicaine in people with Local Anesthetic, run by Basque Health Service at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 3 Feb 2012. 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 Spain. 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?
effectiveness of administering levo-bupicaine to control postoperative pain. (time frame: 48 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 NCT01389934, which also lists 2 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 3 Feb 2012.