Short Duration Lower Limb Surgery Via Spinal AnaesthesiaPhase 2NCT02481505
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
A Phase 2 study testing Chloroprocaine HCl 1% in people with Short Duration Lower Limb Surgery Via Spinal Anaesthesia, run by Sintetica SA at 1 site in Italy.
Trial summary
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Short Duration Lower Limb Surgery Via Spinal Anaesthesia
- What is being tested?
- Chloroprocaine HCl 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block
- Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- ASA physical status: I-II
- Informed consent: signed written informed consent before inclusion in the study 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Who cannot join
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: III-V
- Further anaesthesia: patients expected to require further anaesthesia
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
Show all 10Show fewer
- Drug, alcohol: history of drug or alcohol abuse
- Blood donation: blood donations in the 3 months before this study
- Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
- Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy) 11. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
Read the detailed description
To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)
- Being tested
- Chloroprocaine HCl 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine HCl 1%Drug
Also called Ampres 1%
Intrathecal Route
| Study group | Role | What they receive |
|---|---|---|
| 3 mL Chloroprocaine HCl 1% | Experimental | Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) Receives: Drug: Chloroprocaine HCl 1% |
| 4 mL Chloroprocaine HCl 1% | Experimental | Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) Receives: Drug: Chloroprocaine HCl 1% |
| 5 mL Chloroprocaine HCl 1% | Experimental | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Receives: Drug: Chloroprocaine HCl 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Regression of Spinal Block
When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)
Measured: Up to 5 hours after regression of two dermatomers
Secondary outcomes (23)
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block.
Measured: Up to 40 min after spinal injection
Time to Onset of Motor Block
Time period from spinal injection (time 0 h) to achievement of motor block
Measured: Up to 40 min after spinal injection
Time to Readiness for Surgery
Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12
Measured: Up to 40 min after spinal injection
Time to Regression of Spinal Block
Measured: Up to 1 h and 40 min after readiness for surgery
Time to Resolution of Sensory Block to S1(Min)
Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1
Measured: Up to 5 h after regression of two dermatomers
Time to Resolution of Motor Block
Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)
Measured: Up to 5 h after regression of two dermatomers
Time to Unassisted Ambulation
Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted
Measured: Up to 5 h after regression of two dermatomers
Sensory Block Metameric Level
Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1
Measured: Up to 5 h after regression of two dermatomers
Maximum Level of Sensory Block
Maximum metameric level of sensory block (decreased or absent sensation) achieved
Measured: Up to 1 h and 40 min after readiness for surgery
Time to Maximum Level of Sensory Block
Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block)
Measured: Up to 1 h and 40 min after readiness for surgery
Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block
Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block
Measured: Up to 5 h after regression of two dermatomers
Time to Eligibility for Home Discharge
Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time
Measured: Expected up to 24 hrs post surgery
Time to First Spontaneous Urine Voiding
Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
Measured: Expected up to 24 hrs post surgery
Time to First Post-operative Analgesia
Time from spinal injection (time 0 h) to first post-operative analgesia
Measured: Expected up to 24 hrs post surgery
Time to Administration of Rescue Anaesthesia or Rescue Analgesia
Measured: Expected up to 24 hrs post surgery
Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma
Measured: at pre-dose, 5, 10, 30 and 60 min after spinal puncture
Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine
Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
Measured: at the time of first urine voiding post surgery
Treatment-emergent Adverse Events (TEAEs)
All AEs occurring or worsening after the dose of IMP
Measured: Up to Day 6 +/- 1 after spinal puncture
Transient Neurological Symptoms (TNS)
Measured: Up to Day 6 +/- 1 after spinal puncture
Pain Assessment at the Site of Injection and at the Site of Surgery
Number of patients with pain at the site of injection and at the site of surgery
Measured: Up to Day 6 +/- 1 after spinal puncture
Heart Rate
The following normal ranges Heart Rate parameters will be used:
50-90 beats/min
Measured: Expected up to 24 hrs post surgery
Blood Pressure
The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used:
Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg
Measured: Expected up to 24 hrs post surgery
SpO2
The following normal ranges SpO2 parameters will be used:
Peripheral Oxygen Saturation: ≥ 95%
Measured: Expected up to 24 hrs post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Duration Lower Limb Surgery Via Spinal AnaesthesiaStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Responsible party
- Sponsor
- Investigators
- Stefano MD Bonarelli, Principal investigator, Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481505
- Sponsor's protocol ID
- CHL.1/02-2014
- Other IDs
- 2014-003778-17, 2014
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2015
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9.
PubMed 33610175
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients
- ClinicalTrials.gov ID
- NCT02481505
- Acronym / sponsor ID
- CHL.1/02-2014
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
Detailed description
To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 mL Chloroprocaine HCl 1% | Experimental | Drug: Chloroprocaine HCl 1%Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) |
| 4 mL Chloroprocaine HCl 1% | Experimental | Drug: Chloroprocaine HCl 1%Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) |
| 5 mL Chloroprocaine HCl 1% | Experimental | Drug: Chloroprocaine HCl 1%Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block
- Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- ASA physical status: I-II
- Informed consent: signed written informed consent before inclusion in the study 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Key exclusion criteria (10 listed)
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: III-V
- Further anaesthesia: patients expected to require further anaesthesia
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
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 |
|---|---|---|
| Chloroprocaine HCl 1%Also: Ampres 1%Intrathecal Route | Drug | 3 mL Chloroprocaine HCl 1%, 4 mL Chloroprocaine HCl 1%, 5 mL Chloroprocaine HCl 1% |
Primary outcome
Time to Regression of Spinal Block
Time frame: Up to 5 hours after regression of two dermatomers
When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)
23 secondary outcomes
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
Time frame: Up to 40 min after spinal injection
Time to Onset of Motor Block
Time frame: Up to 40 min after spinal injection
Time to Readiness for Surgery
Time frame: Up to 40 min after spinal injection
Time to Regression of Spinal Block
Time frame: Up to 1 h and 40 min after readiness for surgery
Time to Resolution of Sensory Block to S1(Min)
Time frame: Up to 5 h after regression of two dermatomers
Time to Resolution of Motor Block
Time frame: Up to 5 h after regression of two dermatomers
Time to Unassisted Ambulation
Time frame: Up to 5 h after regression of two dermatomers
Sensory Block Metameric Level
Time frame: Up to 5 h after regression of two dermatomers
Maximum Level of Sensory Block
Time frame: Up to 1 h and 40 min after readiness for surgery
Time to Maximum Level of Sensory Block
Time frame: Up to 1 h and 40 min after readiness for surgery
Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block
Time frame: Up to 5 h after regression of two dermatomers
Time to Eligibility for Home Discharge
Time frame: Expected up to 24 hrs post surgery
Time to First Spontaneous Urine Voiding
Time frame: Expected up to 24 hrs post surgery
Time to First Post-operative Analgesia
Time frame: Expected up to 24 hrs post surgery
Time to Administration of Rescue Anaesthesia or Rescue Analgesia
Time frame: Expected up to 24 hrs post surgery
Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma
Time frame: at pre-dose, 5, 10, 30 and 60 min after spinal puncture
Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine
Time frame: at the time of first urine voiding post surgery
Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 6 +/- 1 after spinal puncture
Transient Neurological Symptoms (TNS)
Time frame: Up to Day 6 +/- 1 after spinal puncture
Pain Assessment at the Site of Injection and at the Site of Surgery
Time frame: Up to Day 6 +/- 1 after spinal puncture
Heart Rate
Time frame: Expected up to 24 hrs post surgery
Blood Pressure
Time frame: Expected up to 24 hrs post surgery
SpO2
Time frame: Expected up to 24 hrs post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33610175Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9.
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.
Stefano MD Bonarelli principal investigator
Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloroprocaine HCl 1% in people with Short Duration Lower Limb Surgery Via Spinal Anaesthesia, run by Sintetica SA 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 4 inclusion and 10 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 18 May 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Regression of Spinal Block (time frame: Up to 5 hours after regression of two dermatomers). 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 NCT02481505, 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 18 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.