Regional AnesthesiaNEURALNCT07238933
Neurological Events and Unforeseen Risks After Locoregional-anesthesia
An observational study of Regional Anesthesia and Regional Anesthesia Block, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 4 sites in Italy.
Trial summary
This is a multicenter, prospective, observational study aimed at determining the incidence of neurological and non-neurological complications following locoregional anesthesia procedures. The study will collect data on events such as nerve injury, hematoma, pneumothorax, and local anesthetic systemic toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia, Regional Anesthesia Block
- What is being tested?
- Observational assessment after regional anesthesia
- How many people
- 3,396 participants
- Where
- 4 sitesItaly
- Study dates
- 18 Feb 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (≥18 years) undergoing single-shot locoregional anesthesia of the upper limb, lower limb, or fascial blocks.
Who may be able to join
- Age ≥ 18 years.
- Scheduled to undergo a single-shot nerve or fascial plane block.
- Ability to provide written informed consent.
Who cannot join
- Performance of more than one single-shot nerve or fascial plane block within the same anatomical region or sensory distribution during the same procedure.
- Use of continuous nerve or fascial plane catheter-based anesthesia.
- Presence of a language barrier that, in the investigator's judgment, would prevent adequate follow-up.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, Bergamo, 24127
Dr. Bugada, +39 06 4452816, ricerca@siaarti.it
- Not yet recruiting
Spedali Civili di Brescia
Brescia, Brescia, 25123
Dr. Torrano, +39 06 4452816, vito.torrano@asst-spedalicivili.it
- Recruiting
Azienda Ospedale-Università Padova
Padova, Padova, 35128
Alessandro De Cassai Alessandro De Cassai, 049 821 1111, alessandro.decassai@unipd.it
- Not yet recruiting
Irccs Humanitas Research Hospital
Rozzano, Milan, 20089
Dr. Tasso, +39 06 4452816, francesco.tasso@humanitas.it
About this study
This is a multicenter, prospective, observational study aimed at determining the incidence of neurological and non-neurological complications following locoregional anesthesia procedures. The study will collect data on events such as nerve injury, hematoma, pneumothorax, and local anesthetic systemic toxicity.
Read the detailed description
Locoregional anesthesia is generally considered safe, but rare neurological and systemic complications have been reported. Current data on the true incidence of these complications are limited and often derived from small sample sizes or registries. The NEURAL study aims to fill this knowledge gap by prospectively collecting data on complications following single-shot nerve blocks in the upper limb, lower limb, and fascial plane. In addition to incidence, the study will investigate potential risk factors for these complications.
- Conditions
- Regional Anesthesia, Regional Anesthesia Block
- Being tested
- Observational assessment after regional anesthesia
- Keywords
- Nerve Injury, Pneumothorax, Local Anesthetic Systemic, Toxicity, Upper limb block, Lower limb block, Fascial plane block
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessment after regional anesthesiaOther
Adult patients undergoing single-shot regional anesthesia, including:
Upper limb blocks - interscalene, superior trunk, supraclavicular, infraclavicular (coracoid, retroclavicular, costoclavicular), suprascapular (anterior, posterior), axillary, and superficial/intermediate/deep cervical plexus blocks.
Lower limb blocks - lumbar, sacral, fascia iliaca (supra/infrainguinal), adductor canal, PENG, femoral, femoral triangle, sciatic (anterior, transgluteal, infragluteal, popliteal), nerve to vastus medialis, genicular, IPACK, common peroneal, ankle, and pudendal blocks.
Fascial plane blocks - rectus sheath, ilioinguinal/iliohypogastric, TAP (standard/subcostal/midaxillary), ESP, serratus anterior (deep/superficial), parasternal intercostal (superficial/deep), interpectoral, transversalis fascia, rhomboid intercostal, retrolaminar, quadratus lumborum (anterior/lateral/posterior), paravertebral, intertransverse process, and pectoserratus blocks.
| Study group | Role | What they receive |
|---|---|---|
| Single group of enrolled patients | Adult patients (≥18 years) undergoing single-shot upper limb, lower limb, or fascial plane regional anesthesia. All participants meeting inclusion criteria and providing informed consent will be enrolled consecutively. Receives: Other: Observational assessment after regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia
Incidence of any major complication - including nerve injury, hematoma requiring medical intervention, pneumothorax, or local anesthetic systemic toxicity (LAST) - following single-shot locoregional anesthesia. The rate is calculated as the number of procedures with at least one complication divided by the total number of procedures performed.
Measured: From the time of the locoregional anesthesia procedure up to 30 days post-procedure (periprocedural and early postoperative period, with follow-up at 24 hours, 48 hours, 15 days, and 30 days).
Secondary outcomes (12)
Incidence of Complications in Upper Limb Nerve Blocks
Incidence of each complication type (nerve injury, hematoma, pneumothorax, LAST) following upper limb single-shot nerve blocks. Calculated as the number of events divided by the total number of upper limb procedures
Measured: From the procedure to 30 days post-procedure.
Incidence of Complications in Fascial Plane Blocks
Incidence of each complication type (nerve injury, hematoma, pneumothorax, LAST) following fascial plane single-shot blocks.
Measured: From the procedure to 30 days post-procedure.
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age
Measured in years
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender
Using a dichotomic male/female framework
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index
Calculated dividing a person's weight in kilograms by the square of their height in meters (BMI = weight ÷ height²) (kg/cm²)
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities
Hypertension, diabetes, and central or peripheral neuropathies each expressed dichotomically as "Yes" (present) or "No" (absent).
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy
Use of anticogulants and/or antiplatetets drugs expressed as a Yes or No
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure
Use of any sedative agents during the block procedure reported as a Yes or No
Measured: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection
Reported pain during the injection of local anesthetics expressed as a Yes or No
Measured: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance
Use of ultrasound guidance to perform the block, measured with a "Yes" or "No" variable
Measured: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block
Name, volume(ml) and dose(mg) of the local anesthetic used to perform the block
Measured: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block
Name, volume(ml) and dose(mcg) of the adjuvants used to perform the block
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start18 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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 Regional AnesthesiaStudies 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
- 3,396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro De Cassai Prof., MD, Principal investigator, UOC Istituto di Anestesia e Rianimazione, Azienda Ospedale Università di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238933
- Sponsor's protocol ID
- NEURAL
- Acronym
- NEURAL
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McLeod GA, Sadler A, Hales TG. Traumatic needle damage to nerves during regional anesthesia: presentation of a novel mechanotransduction hypothesis. Reg Anesth Pain Med. 2022 Jul 25:rapm-2022-103583. doi: 10.1136/rapm-2022-103583. Online ahead of print.
PubMed 35878962Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local Anesthetic Systemic Toxicity: A Narrative Literature Review and Clinical Update on Prevention, Diagnosis, and Management. Plast Reconstr Surg. 2019 Sep;144(3):783-795. doi: 10.1097/PRS.0000000000005989.
PubMed 31461049Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286.
PubMed 26288034El-Boghdadly K, Wolmarans M, Stengel AD, Albrecht E, Chin KJ, Elsharkawy H, Kopp S, Mariano ER, Xu JL, Adhikary S, Altiparmak B, Barrington MJ, Bloc S, Blanco R, Boretsky K, Borglum J, Breebaart M, Burckett-St Laurent D, Capdevila X, Carvalho B, Chuan A, Coppens S, Costache I, Dam M, Egeler C, Fajardo M, Gadsden J, Gautier PE, Grant SA, Hadzic A, Hebbard P, Hernandez N, Hogg R, Holtz M, Johnson RL, Karmakar MK, Kessler P, Kwofie K, Lobo C, Ludwin D, MacFarlane A, McDonnell J, McLeod G, Merjavy P, Moran E, O'Donnell BD, Parras T, Pawa A, Perlas A, Rojas Gomez MF, Sala-Blanch X, Saporito A, Sinha SK, Soffin EM, Thottungal A, Tsui BCH, Tulgar S, Turbitt L, Uppal V, van Geffen GJ, Volk T, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of abdominal wall, paraspinal, and chest wall blocks. Reg Anesth Pain Med. 2021 Jul;46(7):571-580. doi: 10.1136/rapm-2020-102451.
PubMed 34145070El-Boghdadly K, Albrecht E, Wolmarans M, Mariano ER, Kopp S, Perlas A, Thottungal A, Gadsden J, Tulgar S, Adhikary S, Aguirre J, Agur AMR, Altiparmak B, Barrington MJ, Bedforth N, Blanco R, Bloc S, Boretsky K, Bowness J, Breebaart M, Burckett-St Laurent D, Carvalho B, Chelly JE, Chin KJ, Chuan A, Coppens S, Costache I, Dam M, Desmet M, Dhir S, Egeler C, Elsharkawy H, Bendtsen TF, Fox B, Franco CD, Gautier PE, Grant SA, Grape S, Guheen C, Harbell MW, Hebbard P, Hernandez N, Hogg RMG, Holtz M, Ihnatsenka B, Ilfeld BM, Ip VHY, Johnson RL, Kalagara H, Kessler P, Kwofie MK, Le-Wendling L, Lirk P, Lobo C, Ludwin D, Macfarlane AJR, Makris A, McCartney C, McDonnell J, McLeod GA, Memtsoudis SG, Merjavy P, Moran EML, Nader A, Neal JM, Niazi AU, Njathi-Ori C, O'Donnell BD, Oldman M, Orebaugh SL, Parras T, Pawa A, Peng P, Porter S, Pulos BP, Sala-Blanch X, Saporito A, Sauter AR, Schwenk ES, Sebastian MP, Sidhu N, Sinha SK, Soffin EM, Stimpson J, Tang R, Tsui BCH, Turbitt L, Uppal V, van Geffen GJ, Vermeylen K, Vlassakov K, Volk T, Xu JL, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of upper and lower limb nerve blocks. Reg Anesth Pain Med. 2024 Nov 4;49(11):782-792. doi: 10.1136/rapm-2023-104884.
PubMed 38050174Long B, Chavez S, Gottlieb M, Montrief T, Brady WJ. Local anesthetic systemic toxicity: A narrative review for emergency clinicians. Am J Emerg Med. 2022 Sep;59:42-48. doi: 10.1016/j.ajem.2022.06.017. Epub 2022 Jun 13.
PubMed 35777259
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Events and Unforeseen Risks After Locoregional-anesthesia
- ClinicalTrials.gov ID
- NCT07238933
- Acronym / sponsor ID
- NEURAL / NEURAL
- Conditions
- Regional Anesthesia, Regional Anesthesia Block
- Keywords
- Nerve Injury, Pneumothorax, Local Anesthetic Systemic, Toxicity, Upper limb block, Lower limb block, Fascial plane block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,396 participants (estimated)
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia IntensivaUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Nov 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.
This is a multicenter, prospective, observational study aimed at determining the incidence of neurological and non-neurological complications following locoregional anesthesia procedures. The study will collect data on events such as nerve injury, hematoma, pneumothorax, and local anesthetic systemic toxicity.
Detailed description
Locoregional anesthesia is generally considered safe, but rare neurological and systemic complications have been reported. Current data on the true incidence of these complications are limited and often derived from small sample sizes or registries. The NEURAL study aims to fill this knowledge gap by prospectively collecting data on complications following single-shot nerve blocks in the upper limb, lower limb, and fascial plane. In addition to incidence, the study will investigate potential risk factors for these complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group of enrolled patients | – | Other: Observational assessment after regional anesthesiaAdult patients (≥18 years) undergoing single-shot upper limb, lower limb, or fascial plane regional anesthesia. All participants meeting inclusion criteria and providing informed consent will be enrolled consecutively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) undergoing single-shot locoregional anesthesia of the upper limb, lower limb, or fascial blocks.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Scheduled to undergo a single-shot nerve or fascial plane block.
- Ability to provide written informed consent.
Key exclusion criteria (3 listed)
- Performance of more than one single-shot nerve or fascial plane block within the same anatomical region or sensory distribution during the same procedure.
- Use of continuous nerve or fascial plane catheter-based anesthesia.
- Presence of a language barrier that, in the investigator's judgment, would prevent adequate follow-up.
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 |
|---|---|---|
| Observational assessment after regional anesthesiaAdult patients undergoing single-shot regional anesthesia, including: Upper limb blocks - interscalene, superior trunk, supraclavicular, infraclavicular (coracoid, retroclavicular, costoclavicular), suprascapular (anterior, posterior), axillary, and superficial/intermediate/deep cervical plexus blocks. Lower limb blocks - lumbar, sacral, fascia iliaca (supra/infrainguinal), adductor canal, PENG, femoral, femoral triangle, sciatic (anterior, transgluteal, infragluteal, popliteal), nerve to vastus medialis, genicular, IPACK, common peroneal, ankle, and pudendal blocks. Fascial plane blocks - rectus sheath, ilioinguinal/iliohypogastric, TAP (standard/subcostal/midaxillary), ESP, serratus anterior (deep/superficial), parasternal intercostal (superficial/deep), interpectoral, transversalis fascia, rhomboid intercostal, retrolaminar, quadratus lumborum (anterior/lateral/posterior), paravertebral, intertransverse process, and pectoserratus blocks. | Other | Single group of enrolled patients |
Primary outcome
Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia
Time frame: From the time of the locoregional anesthesia procedure up to 30 days post-procedure (periprocedural and early postoperative period, with follow-up at 24 hours, 48 hours, 15 days, and 30 days).
Incidence of any major complication - including nerve injury, hematoma requiring medical intervention, pneumothorax, or local anesthetic systemic toxicity (LAST) - following single-shot locoregional anesthesia. The rate is calculated as the number of procedures with at least one complication divided by the total number of procedures performed.
12 secondary outcomes
Incidence of Complications in Upper Limb Nerve Blocks
Time frame: From the procedure to 30 days post-procedure.
Incidence of Complications in Fascial Plane Blocks
Time frame: From the procedure to 30 days post-procedure.
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure
Time frame: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance
Time frame: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block
Time frame: Periprocedural
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 35878962McLeod GA, Sadler A, Hales TG. Traumatic needle damage to nerves during regional anesthesia: presentation of a novel mechanotransduction hypothesis. Reg Anesth Pain Med. 2022 Jul 25:rapm-2022-103583. doi: 10.1136/rapm-2022-103583. Online ahead of print.
- Background: PubMed 31461049Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local Anesthetic Systemic Toxicity: A Narrative Literature Review and Clinical Update on Prevention, Diagnosis, and Management. Plast Reconstr Surg. 2019 Sep;144(3):783-795. doi: 10.1097/PRS.0000000000005989.
- Background: PubMed 26288034Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286.
- Background: PubMed 34145070El-Boghdadly K, Wolmarans M, Stengel AD, Albrecht E, Chin KJ, Elsharkawy H, Kopp S, Mariano ER, Xu JL, Adhikary S, Altiparmak B, Barrington MJ, Bloc S, Blanco R, Boretsky K, Borglum J, Breebaart M, Burckett-St Laurent D, Capdevila X, Carvalho B, Chuan A, Coppens S, Costache I, Dam M, Egeler C, Fajardo M, Gadsden J, Gautier PE, Grant SA, Hadzic A, Hebbard P, Hernandez N, Hogg R, Holtz M, Johnson RL, Karmakar MK, Kessler P, Kwofie K, Lobo C, Ludwin D, MacFarlane A, McDonnell J, McLeod G, Merjavy P, Moran E, O'Donnell BD, Parras T, Pawa A, Perlas A, Rojas Gomez MF, Sala-Blanch X, Saporito A, Sinha SK, Soffin EM, Thottungal A, Tsui BCH, Tulgar S, Turbitt L, Uppal V, van Geffen GJ, Volk T, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of abdominal wall, paraspinal, and chest wall blocks. Reg Anesth Pain Med. 2021 Jul;46(7):571-580. doi: 10.1136/rapm-2020-102451.
- Background: PubMed 38050174El-Boghdadly K, Albrecht E, Wolmarans M, Mariano ER, Kopp S, Perlas A, Thottungal A, Gadsden J, Tulgar S, Adhikary S, Aguirre J, Agur AMR, Altiparmak B, Barrington MJ, Bedforth N, Blanco R, Bloc S, Boretsky K, Bowness J, Breebaart M, Burckett-St Laurent D, Carvalho B, Chelly JE, Chin KJ, Chuan A, Coppens S, Costache I, Dam M, Desmet M, Dhir S, Egeler C, Elsharkawy H, Bendtsen TF, Fox B, Franco CD, Gautier PE, Grant SA, Grape S, Guheen C, Harbell MW, Hebbard P, Hernandez N, Hogg RMG, Holtz M, Ihnatsenka B, Ilfeld BM, Ip VHY, Johnson RL, Kalagara H, Kessler P, Kwofie MK, Le-Wendling L, Lirk P, Lobo C, Ludwin D, Macfarlane AJR, Makris A, McCartney C, McDonnell J, McLeod GA, Memtsoudis SG, Merjavy P, Moran EML, Nader A, Neal JM, Niazi AU, Njathi-Ori C, O'Donnell BD, Oldman M, Orebaugh SL, Parras T, Pawa A, Peng P, Porter S, Pulos BP, Sala-Blanch X, Saporito A, Sauter AR, Schwenk ES, Sebastian MP, Sidhu N, Sinha SK, Soffin EM, Stimpson J, Tang R, Tsui BCH, Turbitt L, Uppal V, van Geffen GJ, Vermeylen K, Vlassakov K, Volk T, Xu JL, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of upper and lower limb nerve blocks. Reg Anesth Pain Med. 2024 Nov 4;49(11):782-792. doi: 10.1136/rapm-2023-104884.
- Background: PubMed 35777259Long B, Chavez S, Gottlieb M, Montrief T, Brady WJ. Local anesthetic systemic toxicity: A narrative review for emergency clinicians. Am J Emerg Med. 2022 Sep;59:42-48. doi: 10.1016/j.ajem.2022.06.017. Epub 2022 Jun 13.
- Individual participant dataSharing planned: Undecided
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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.
Alessandro De Cassai Prof., MD principal investigator
UOC Istituto di Anestesia e Rianimazione, Azienda Ospedale Università di Padova
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and Regional Anesthesia Block, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 4 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 3 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Cacciagrano Clinical Reasearch Office SIAARTI (+39 06 4452816, ricerca@siaarti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia (time frame: From the time of the locoregional anesthesia procedure up to 30 days post-procedure (periprocedural and early postoperative period, with follow-up at 24 hours, 48 hours, 15 days, and 30 days).). 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 NCT07238933, 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 11 Sep 2026.