AnesthesiaPhase 4LEVOROPINCT01229241
Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
A Phase 4 study testing local anesthetic in people with Anesthesia and Surgery, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
Trial summary
The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia, Surgery
- What is being tested?
- local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2005to Jul 2011
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or ASA II
- Scheduled for major surgery
- written informed consent
Who cannot join
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- cognitive or mental alterations
- coagulopathy
- piastrinemia < 100.000/mm3
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo
Monza, 20052
IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
About this study
Official title: Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
Read the detailed description
In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy and toxicity.The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
Primary outcome:
Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine during continuous epidural infusion
Secondary outcome:
Assessment of the safety level of the local anesthetic (major difference between haematic concentration of the local anesthetic and neuro-cardiotoxic dose).
Difference of the analgesic efficacy between levobupivacaine and ropivacaine. Differences in collateral effects due to the local anesthetic: hypotension and sensitive block.
Prospective randomized double-blinded clinical trial
- Conditions
- Anesthesia, Surgery
- Being tested
- local anesthetic
- Keywords
- local anesthetic, epidural, pharmacokinetics, plasmatic concentration, epidural continuous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anestheticDrug
Also called Chriocaina, Naropina
postoperative 48h epidural continuous infusion,
- ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
- levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml
| Study group | Role | What they receive |
|---|---|---|
| levobupivacaine | Other | Not described Receives: Drug: local anesthetic |
| ropivacaine | Other | Not described Receives: Drug: local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of the local anesthetics in study
Assessment of the equivalence of the systemic exposition of levobupivacaine and ropivacaine during 48h continuous epidural infusion with in a range of 15%.Blood samples (8) will be taken for farmacological assessment of local anesthetic plasma concentrations at time (hours) 0,+3h,+6h,+12h,+24h,+48h,+54h,+60h
Measured: during 60h after surgery
Secondary outcomes (3)
Assessment of the pharmacological profile of the local anesthetics in study
Assessment of the therapeutic index (plasma concentration of the local anesthetics in study compared to those described in literature to be related to toxic effects).
Measured: during 60h after surgery
Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)
Measured: Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
Difference at least 20% in presentation of collateral effects between the two groups
Measured: Continuous assessment during the 72 h post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJul 2005
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Allegri, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Massimo Allegri, MD, Principal investigator, IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229241
- Sponsor's protocol ID
- 2010-019393-32
- Acronym
- LEVOROPI
- Status last verified
- Jan 2012
- First submitted
- 16 Aug 2010
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perotti L, Cusato M, Ingelmo P, Niebel TL, Somaini M, Riva F, Tinelli C, De Andres J, Fanelli G, Braschi A, Regazzi M, Allegri M. A Comparison of Differences Between the Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion: A Prospective, Randomized, Multicenter, Double-Blind Controlled Trial. Anesth Analg. 2015 Aug;121(2):348-56. doi: 10.1213/ANE.0000000000000775.
PubMed 25977992
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
- ClinicalTrials.gov ID
- NCT01229241
- Acronym / sponsor ID
- LEVOROPI / 2010-019393-32
- Conditions
- Anesthesia, Surgery
- Keywords
- local anesthetic, epidural, pharmacokinetics, plasmatic concentration, epidural continuous infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Oct 2010 (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 aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
Detailed description
In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy and toxicity.The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
Primary outcome:
Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine during continuous epidural infusion
Secondary outcome:
Assessment of the safety level of the local anesthetic (major difference between haematic concentration of the local anesthetic and neuro-cardiotoxic dose).
Difference of the analgesic efficacy between levobupivacaine and ropivacaine. Differences in collateral effects due to the local anesthetic: hypotension and sensitive block.
Prospective randomized double-blinded clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levobupivacaine | Other | Drug: local anesthetic |
| ropivacaine | Other | Drug: local anesthetic |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or ASA II
- Scheduled for major surgery
- written informed consent
Key exclusion criteria (7 listed)
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- cognitive or mental alterations
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 |
|---|---|---|
| local anestheticAlso: Chriocaina, Naropinapostoperative 48h epidural continuous infusion, 1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml 2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml | Drug | levobupivacaine, ropivacaine |
Primary outcome
Plasma concentration of the local anesthetics in study
Time frame: during 60h after surgery
Assessment of the equivalence of the systemic exposition of levobupivacaine and ropivacaine during 48h continuous epidural infusion with in a range of 15%.Blood samples (8) will be taken for farmacological assessment of local anesthetic plasma concentrations at time (hours) 0,+3h,+6h,+12h,+24h,+48h,+54h,+60h
3 secondary outcomes
Assessment of the pharmacological profile of the local anesthetics in study
Time frame: during 60h after surgery
Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)
Time frame: Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
Difference at least 20% in presentation of collateral effects between the two groups
Time frame: Continuous assessment during the 72 h post-surgery
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 20 Jan 2012.
- Derived from this study: PubMed 25977992Perotti L, Cusato M, Ingelmo P, Niebel TL, Somaini M, Riva F, Tinelli C, De Andres J, Fanelli G, Braschi A, Regazzi M, Allegri M. A Comparison of Differences Between the Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion: A Prospective, Randomized, Multicenter, Double-Blind Controlled Trial. Anesth Analg. 2015 Aug;121(2):348-56. doi: 10.1213/ANE.0000000000000775.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Massimo Allegri, MD principal investigator
IRCCS Policlinico San Matteo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing local anesthetic in people with Anesthesia and Surgery, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
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 3 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: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. 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?
Plasma concentration of the local anesthetics in study (time frame: during 60h after surgery). 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 NCT01229241, which also lists 1 linked publication.
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 Jan 2012.