Local Anesthetic ToxicityNCT05592691
Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery
An observational study of Local Anesthetic Toxicity and Regional Anesthesia Morbidity, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Primary aim: observe the incidence of systemic toxicity from local anesthetic (LAST) after performing fascial blocks in patients undergoing elective cardio-thoracic and abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Anesthetic Toxicity, Regional Anesthesia Morbidity, Postoperative Pain
- What is being tested?
- Fascial block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2022to 30 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involves the enrollment of patients who will undergo elective cardio-thoracic and / or abdominal surgery at the A.O.U. Città della Salute e della Scienza of Turin, with clinical indications for the execution of band blocks for analgesic purposes.
Who may be able to join
- Patients undergoing elective cardio-thoracic and abdominal surgery with indications for the execution of fascial block
- Signature of the informed consent form.
Who cannot join
- Lack of informed consent form.
- Previous neuropsychiatric pathologies or neuropathies of the back / trunk
- Severe renal insufficiency (GFR <30ml / min)
- Severe hepatic insufficiency or alteration of liver enzymes
- Contraindications to LRA procedures (injection site infection, coagulopathy, allergy / hypersensitivity to local anesthetics)
- Pregnancy
- Hypoalbuminemia
- Hospitalization in intensive care and / or post-operative sedation> 24 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Turin, 10100
Luca Brazzi, PhD, +39 011 6335501, luca.brazzi@unito.it
Edoardo Ceraolo, MD
About this study
Official title: Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery: an Observational, Monocentric Study
Primary aim: observe the incidence of systemic toxicity from local anesthetic (LAST) after performing fascial blocks in patients undergoing elective cardio-thoracic and abdominal surgery.
Secondary aim: describe the pharmacokinetic profile of the local anesthetic (ropivacaine) and assess peri-procedural complications, post-operative pain and opiate consumption in the first 24 hours.
Read the detailed description
Loco-regional anesthesia (LRA) procedures have acquired, in recent years, increasing importance in the peri-operative control of pain in the field of cardio-thoracic and abdominal surgery. To date, they are recognized as part of the multimodal analgesia underlying the Enhanced Recovery After Surgery (ERAS) protocols as they have demonstrated a better efficacy in post-operative pain control than the use of opiates alone and allow a significant reduction in the use of opioids in the postoperative period.
The advent of ultrasound-guided LRA procedures has led to the development of numerous fascial blocks, which involve the injection, at the level of the muscle-fascial planes, of an abundant volume of low-concentration local anesthetic to allow spread to adjacent nerve structures. The fascial blocks represent a valid alternative to epidural analgesia for the control of postoperative pain in the thoracoabdominal area, as they are characterized by a rapid learning curve and a lower risk of periprocedural complications compared to neuraxial anesthesia procedures.
The main chest wall nerve blocks used in clinical practice include the pectoral nerve block (PECS1 and PECS2) and serrate anterior plane block (SAP) at the level of the anterior chest wall; the spinal erector plane (ESP) block and the paravertebral block at the level of the posterior thoracic wall.
LRA techniques also play a fundamental role in the field of abdominal surgery, especially in the context of multimodal analgesia, aiming to reduce consumption and, consequently, the secondary side effects of the use of opioids.
In the case of laparotomic major abdominal surgery, the use of epidural analgesia has been shown to be effective in reducing post-operative pain, opioid consumption, and recovery of gastrointestinal function, but has not shown a significant reduction in the duration of hospitalization and of post-operative complications.
Subarachnoid analgesia is mainly indicated in laparoscopic abdominal surgery. Numerous studies have shown an efficacy similar to epidural anesthesia in controlling pain and reducing opioid consumption as well as allowing early patient mobilization and a shorter length of hospital stay.
The transverse abdominal plane (TAP) block has a rapid learning curve and has been shown to be effective in controlling postoperative analgesia, reducing opioids consumption and reducing hospital stay.
The lumbar square (QoL) block has a greater efficacy than other abdominal wall blocks on the visceral component of pain. A recent meta-analysis demonstrated greater efficacy than TAP in the control of post-operative pain and guarantees a longer duration of analgesia.
The effectiveness of the anesthetic depends on its local action at the level of the nervous structures "wetted" by the drug; a variable amount of local anesthetic undergoes systemic absorption and might be responsible for part of the analgesic effect, but above all for the possible appearance of systemic side effects.10 The amount of drug redistributing in the blood depends on the total dose of the drug administered, the route of administration, and the vascularity of the injection site.
Ropivacaine is a long-acting amide local anesthetic frequently used in LRA procedures. Unlike other drugs of the same family, the levorotatory enantiomer S-Ropivacaine is characterized by reduced lipophilicity and this determines a lower risk of toxicity to the Central Nervous System (CNS) and cardiovascular system (CVS). The drug exhibits high plasma protein binding (α1-acid glycoprotein), linear absorption kinetics, hepatic metabolism, and renal elimination.
Systemic toxicity from Local anesthetic (LAST) represents a complication of local anesthetic administration and is directly dependent on the plasma concentration of the drug. The signs and symptoms of LAST occur progressively and mainly affect the CNS (visual disturbances, perioral hypoaesthesia, dizziness, euphoria, muscle stiffness, spasms, convulsions) and the CVS system (hypotension, bradycardia, arrhythmias, cardiac arrest).
The study aims to observe the onset of local anesthetic toxicity (LAST) after performing fascial blocks in patients undergoing elective cardiothoracic and abdominal surgery.
- Being tested
- Fascial block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial blockProcedure or surgery
The end of the drug infusion will be considered the time zero (T0); subsequently blood samples (4ml) will be taken at pre-established time intervals (after 5, 15, 30, 60, 120 and 180 minutes). Blood samples will be collected in test tubes and centrifuged within 1 hour of collection; subsequently they will be stored at a low temperature and transported to the reference analysis laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Patients undergoing fascial blocks in elective cardio-thoracic and abdominal surgery. Receives: Procedure: Fascial block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
Measured: 6 hours after surgery
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
Measured: 12 hours after surgery
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
Measured: 24 hours after surgery
Secondary outcomes (23)
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 5 minutes from the fascial block execution
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 15 minutes from the fascial block execution
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 30 minutes from the fascial block execution
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 60 minutes from the fascial block execution
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 120 minutes from the fascial block execution
Ropivacaine concentration
Ropivacaine plasma concentration
Measured: 180 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 5 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 15 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 30 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 60 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 120 minutes from the fascial block execution
Ropivacaine latency time
Ropivacaine maximum plasma concentration and latency time between the execution of the block and the achievement of Cmax
Measured: 180 minutes from the fascial block execution
Anesthesia effectiveness
Global extension of the anesthetized skin surface, measured by Pinprick test.
Measured: Immediately after fascial block
Post-operative pain
Pain after awakening, estimated using the numeric scale for pain assessment (min 0 max 10, 10 equals worst outcome)
Measured: 0 hours after awakening
Post-operative pain
Pain after awakening, estimated using the numeric scale for pain assessment (min 0 max 10, 10 equals worst outcome)
Measured: 1 hour after awakening
Post-operative pain
Pain after awakening, estimated using the numeric scale for pain assessment (min 0 max 10, 10 equals worst outcome)
Measured: 6 hours after awakening
Post-operative pain
Pain after awakening, estimated using the numeric scale for pain assessment (min 0 max 10, 10 equals worst outcome)
Measured: 12 hours after awakening
Post-operative pain
Pain after awakening, estimated using the numeric scale for pain assessment (min 0 max 10, 10 equals worst outcome)
Measured: 24 hours after awakening
Opioid requirement
Pain after awakening, estimated using morphine equivalent milligrams
Measured: 0 hours after awakening
Opioid requirement
Pain after awakening, estimated using morphine equivalent milligrams
Measured: 1 hour after awakening
Opioid requirement
Pain after awakening, estimated using morphine equivalent milligrams
Measured: 6 hours after awakening
Opioid requirement
Pain after awakening, estimated using morphine equivalent milligrams
Measured: 12 hours after awakening
Opioid requirement
Pain after awakening, estimated using morphine equivalent milligrams
Measured: 24 hours after awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start29 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Local Anesthetic ToxicityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Brazzi, University of Turin, Italy
- Investigators
- Edoardo Ceraolo, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592691
- Sponsor's protocol ID
- PRAST
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Crumley S, Schraag S. The role of local anaesthetic techniques in ERAS protocols for thoracic surgery. J Thorac Dis. 2018 Mar;10(3):1998-2004. doi: 10.21037/jtd.2018.02.48.
PubMed 29707356Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
PubMed 33426660Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
PubMed 32062870Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229Hughes MJ, Ventham NT, McNally S, Harrison E, Wigmore S. Analgesia after open abdominal surgery in the setting of enhanced recovery surgery: a systematic review and meta-analysis. JAMA Surg. 2014 Dec;149(12):1224-30. doi: 10.1001/jamasurg.2014.210.
PubMed 25317633Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed. 2008 Aug;79(2):92-105.
PubMed 18788503
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery: an Observational, Monocentric Study
- ClinicalTrials.gov ID
- NCT05592691
- Acronym / sponsor ID
- PRAST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Oct 2022 (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.
Primary aim: observe the incidence of systemic toxicity from local anesthetic (LAST) after performing fascial blocks in patients undergoing elective cardio-thoracic and abdominal surgery.
Secondary aim: describe the pharmacokinetic profile of the local anesthetic (ropivacaine) and assess peri-procedural complications, post-operative pain and opiate consumption in the first 24 hours.
Detailed description
Loco-regional anesthesia (LRA) procedures have acquired, in recent years, increasing importance in the peri-operative control of pain in the field of cardio-thoracic and abdominal surgery. To date, they are recognized as part of the multimodal analgesia underlying the Enhanced Recovery After Surgery (ERAS) protocols as they have demonstrated a better efficacy in post-operative pain control than the use of opiates alone and allow a significant reduction in the use of opioids in the postoperative period.
The advent of ultrasound-guided LRA procedures has led to the development of numerous fascial blocks, which involve the injection, at the level of the muscle-fascial planes, of an abundant volume of low-concentration local anesthetic to allow spread to adjacent nerve structures. The fascial blocks represent a valid alternative to epidural analgesia for the control of postoperative pain in the thoracoabdominal area, as they are characterized by a rapid learning curve and a lower risk of periprocedural complications compared to neuraxial anesthesia procedures.
The main chest wall nerve blocks used in clinical practice include the pectoral nerve block (PECS1 and PECS2) and serrate anterior plane block (SAP) at the level of the anterior chest wall; the spinal erector plane (ESP) block and the paravertebral block at the level of the posterior thoracic wall.
LRA techniques also play a fundamental role in the field of abdominal surgery, especially in the context of multimodal analgesia, aiming to reduce consumption and, consequently, the secondary side effects of the use of opioids.
In the case of laparotomic major abdominal surgery, the use of epidural analgesia has been shown to be effective in reducing post-operative pain, opioid consumption, and recovery of gastrointestinal function, but has not shown a significant reduction in the duration of hospitalization and of post-operative complications.
Subarachnoid analgesia is mainly indicated in laparoscopic abdominal surgery. Numerous studies have shown an efficacy similar to epidural anesthesia in controlling pain and reducing opioid consumption as well as allowing early patient mobilization and a shorter length of hospital stay.
The transverse abdominal plane (TAP) block has a rapid learning curve and has been shown to be effective in controlling postoperative analgesia, reducing opioids consumption and reducing hospital stay.
The lumbar square (QoL) block has a greater efficacy than other abdominal wall blocks on the visceral component of pain. A recent meta-analysis demonstrated greater efficacy than TAP in the control of post-operative pain and guarantees a longer duration of analgesia.
The effectiveness of the anesthetic depends on its local action at the level of the nervous structures "wetted" by the drug; a variable amount of local anesthetic undergoes systemic absorption and might be responsible for part of the analgesic effect, but above all for the possible appearance of systemic side effects.10 The amount of drug redistributing in the blood depends on the total dose of the drug administered, the route of administration, and the vascularity of the injection site.
Ropivacaine is a long-acting amide local anesthetic frequently used in LRA procedures. Unlike other drugs of the same family, the levorotatory enantiomer S-Ropivacaine is characterized by reduced lipophilicity and this determines a lower risk of toxicity to the Central Nervous System (CNS) and cardiovascular system (CVS). The drug exhibits high plasma protein binding (α1-acid glycoprotein), linear absorption kinetics, hepatic metabolism, and renal elimination.
Systemic toxicity from Local anesthetic (LAST) represents a complication of local anesthetic administration and is directly dependent on the plasma concentration of the drug. The signs and symptoms of LAST occur progressively and mainly affect the CNS (visual disturbances, perioral hypoaesthesia, dizziness, euphoria, muscle stiffness, spasms, convulsions) and the CVS system (hypotension, bradycardia, arrhythmias, cardiac arrest).
The study aims to observe the onset of local anesthetic toxicity (LAST) after performing fascial blocks in patients undergoing elective cardiothoracic and abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Procedure: Fascial blockPatients undergoing fascial blocks in elective cardio-thoracic and abdominal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involves the enrollment of patients who will undergo elective cardio-thoracic and / or abdominal surgery at the A.O.U. Città della Salute e della Scienza of Turin, with clinical indications for the execution of band blocks for analgesic purposes.
Key inclusion criteria (2 listed)
- Patients undergoing elective cardio-thoracic and abdominal surgery with indications for the execution of fascial block
- Signature of the informed consent form.
Key exclusion criteria (8 listed)
- Lack of informed consent form.
- Previous neuropsychiatric pathologies or neuropathies of the back / trunk
- Severe renal insufficiency (GFR <30ml / min)
- Severe hepatic insufficiency or alteration of liver enzymes
- Contraindications to LRA procedures (injection site infection, coagulopathy, allergy / hypersensitivity to local anesthetics)
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 |
|---|---|---|
| Fascial blockThe end of the drug infusion will be considered the time zero (T0); subsequently blood samples (4ml) will be taken at pre-established time intervals (after 5, 15, 30, 60, 120 and 180 minutes). Blood samples will be collected in test tubes and centrifuged within 1 hour of collection; subsequently they will be stored at a low temperature and transported to the reference analysis laboratory. | Procedure or surgery | Study Cohort |
Primary outcome
Incidence of systemic toxicity from local anesthetic signs and symptoms.
Time frame: 6 hours after surgery
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
Incidence of systemic toxicity from local anesthetic signs and symptoms.
Time frame: 12 hours after surgery
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
Incidence of systemic toxicity from local anesthetic signs and symptoms.
Time frame: 24 hours after surgery
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
23 secondary outcomes
Ropivacaine concentration
Time frame: 5 minutes from the fascial block execution
Ropivacaine concentration
Time frame: 15 minutes from the fascial block execution
Ropivacaine concentration
Time frame: 30 minutes from the fascial block execution
Ropivacaine concentration
Time frame: 60 minutes from the fascial block execution
Ropivacaine concentration
Time frame: 120 minutes from the fascial block execution
Ropivacaine concentration
Time frame: 180 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 5 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 15 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 30 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 60 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 120 minutes from the fascial block execution
Ropivacaine latency time
Time frame: 180 minutes from the fascial block execution
Anesthesia effectiveness
Time frame: Immediately after fascial block
Post-operative pain
Time frame: 0 hours after awakening
Post-operative pain
Time frame: 1 hour after awakening
Post-operative pain
Time frame: 6 hours after awakening
Post-operative pain
Time frame: 12 hours after awakening
Post-operative pain
Time frame: 24 hours after awakening
Opioid requirement
Time frame: 0 hours after awakening
Opioid requirement
Time frame: 1 hour after awakening
Opioid requirement
Time frame: 6 hours after awakening
Opioid requirement
Time frame: 12 hours after awakening
Opioid requirement
Time frame: 24 hours after awakening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 29707356Crumley S, Schraag S. The role of local anaesthetic techniques in ERAS protocols for thoracic surgery. J Thorac Dis. 2018 Mar;10(3):1998-2004. doi: 10.21037/jtd.2018.02.48.
- Background: PubMed 33426660Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
- Background: PubMed 32062870Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
- Background: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Background: PubMed 25317633Hughes MJ, Ventham NT, McNally S, Harrison E, Wigmore S. Analgesia after open abdominal surgery in the setting of enhanced recovery surgery: a systematic review and meta-analysis. JAMA Surg. 2014 Dec;149(12):1224-30. doi: 10.1001/jamasurg.2014.210.
- Background: PubMed 18788503Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed. 2008 Aug;79(2):92-105.
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Education, Questionnaires
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.
Edoardo Ceraolo, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Anesthetic Toxicity and Regional Anesthesia Morbidity, run by University of Turin, Italy at 1 site 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 2 inclusion and 8 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 3 Nov 2022. 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 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.
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?
Contact Luca Brazzi, Professor ((+39) 011 633 5505, luca.brazzi@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of systemic toxicity from local anesthetic signs and symptoms. (time frame: 6 hours after surgery). 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 NCT05592691, which also lists 6 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 Nov 2022.