- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02481505
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
April 26, 2021 updated by: Sintetica SA
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bologna, Italy, 40136
- Stefano Bonarelli
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3 mL Chloroprocaine HCl 1%
Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)
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Intrathecal Route
Other Names:
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Experimental: 4 mL Chloroprocaine HCl 1%
Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)
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Intrathecal Route
Other Names:
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Experimental: 5 mL Chloroprocaine HCl 1%
Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)
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Intrathecal Route
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Regression of Spinal Block
Time Frame: Up to 5 hours after regression of two dermatomers
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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)
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Up to 5 hours after regression of two dermatomers
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
Time Frame: Up to 40 min after spinal injection
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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.
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Up to 40 min after spinal injection
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Time to Onset of Motor Block
Time Frame: Up to 40 min after spinal injection
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Time period from spinal injection (time 0 h) to achievement of motor block
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Up to 40 min after spinal injection
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Time to Readiness for Surgery
Time Frame: Up to 40 min after spinal injection
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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
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Up to 40 min after spinal injection
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Time to Regression of Spinal Block
Time Frame: Up to 1 h and 40 min after readiness for surgery
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Up to 1 h and 40 min after readiness for surgery
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Time to Resolution of Sensory Block to S1(Min)
Time Frame: Up to 5 h after regression of two dermatomers
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Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1
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Up to 5 h after regression of two dermatomers
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Time to Resolution of Motor Block
Time Frame: Up to 5 h after regression of two dermatomers
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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)
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Up to 5 h after regression of two dermatomers
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Time to Unassisted Ambulation
Time Frame: Up to 5 h after regression of two dermatomers
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Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted
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Up to 5 h after regression of two dermatomers
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Sensory Block Metameric Level
Time Frame: Up to 5 h after regression of two dermatomers
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Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1
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Up to 5 h after regression of two dermatomers
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Maximum Level of Sensory Block
Time Frame: Up to 1 h and 40 min after readiness for surgery
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Maximum metameric level of sensory block (decreased or absent sensation) achieved
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Up to 1 h and 40 min after readiness for surgery
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Time to Maximum Level of Sensory Block
Time Frame: Up to 1 h and 40 min after readiness for surgery
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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)
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Up to 1 h and 40 min after readiness for surgery
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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
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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
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Up to 5 h after regression of two dermatomers
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Time to Eligibility for Home Discharge
Time Frame: Expected up to 24 hrs post surgery
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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
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Expected up to 24 hrs post surgery
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Time to First Spontaneous Urine Voiding
Time Frame: Expected up to 24 hrs post surgery
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Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
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Expected up to 24 hrs post surgery
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Time to First Post-operative Analgesia
Time Frame: Expected up to 24 hrs post surgery
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Time from spinal injection (time 0 h) to first post-operative analgesia
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Expected up to 24 hrs post surgery
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Time to Administration of Rescue Anaesthesia or Rescue Analgesia
Time Frame: Expected up to 24 hrs post surgery
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Expected up to 24 hrs post surgery
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Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma
Time Frame: at pre-dose, 5, 10, 30 and 60 min after spinal puncture
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at pre-dose, 5, 10, 30 and 60 min after spinal puncture
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Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine
Time Frame: at the time of first urine voiding post surgery
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Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
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at the time of first urine voiding post surgery
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Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 6 +/- 1 after spinal puncture
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All AEs occurring or worsening after the dose of IMP
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Up to Day 6 +/- 1 after spinal puncture
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Transient Neurological Symptoms (TNS)
Time Frame: Up to Day 6 +/- 1 after spinal puncture
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Up to Day 6 +/- 1 after spinal puncture
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Pain Assessment at the Site of Injection and at the Site of Surgery
Time Frame: Up to Day 6 +/- 1 after spinal puncture
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Number of patients with pain at the site of injection and at the site of surgery
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Up to Day 6 +/- 1 after spinal puncture
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Heart Rate
Time Frame: Expected up to 24 hrs post surgery
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The following normal ranges Heart Rate parameters will be used: 50-90 beats/min |
Expected up to 24 hrs post surgery
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Blood Pressure
Time Frame: Expected up to 24 hrs post surgery
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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 |
Expected up to 24 hrs post surgery
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SpO2
Time Frame: Expected up to 24 hrs post surgery
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The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% |
Expected up to 24 hrs post surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefano MD Bonarelli, Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
June 2, 2015
First Submitted That Met QC Criteria
June 22, 2015
First Posted (Estimate)
June 25, 2015
Study Record Updates
Last Update Posted (Actual)
May 18, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHL.1/02-2014
- 2014-003778-17 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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