Clinical trial NCT02481505: Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Lead sponsor: Sintetica SA
Sponsor class: INDUSTRY
Collaborators: name: Cross S.A.
First posted: 2015-06-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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)

Eligibility criteria: Inclusion Criteria:

1. 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
2. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
3. ASA physical status: I-II
4. 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:

1. 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
2. ASA physical status: III-V
3. Further anaesthesia: patients expected to require further anaesthesia
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
5. 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.
6. 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
7. Drug, alcohol: history of drug or alcohol abuse
8. Blood donation: blood donations in the 3 months before this study
9. Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
10. 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.

Primary outcomes:
measure: Time to Regression of Spinal Block
timeFrame: Up to 5 hours after regression of two dermatomers
Secondary outcomes:
measure: Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
timeFrame: Up to 40 min after spinal injection
measure: Time to Onset of Motor Block
timeFrame: Up to 40 min after spinal injection
measure: Time to Readiness for Surgery
timeFrame: Up to 40 min after spinal injection
measure: Time to Regression of Spinal Block
timeFrame: Up to 1 h and 40 min after readiness for surgery
measure: Time to Resolution of Sensory Block to S1(Min)
timeFrame: Up to 5 h after regression of two dermatomers
measure: Time to Resolution of Motor Block
timeFrame: Up to 5 h after regression of two dermatomers
measure: Time to Unassisted Ambulation
timeFrame: Up to 5 h after regression of two dermatomers
measure: Sensory Block Metameric Level
timeFrame: Up to 5 h after regression of two dermatomers
measure: Maximum Level of Sensory Block
timeFrame: Up to 1 h and 40 min after readiness for surgery
measure: Time to Maximum Level of Sensory Block
timeFrame: Up to 1 h and 40 min after readiness for surgery
measure: Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block
timeFrame: Up to 5 h after regression of two dermatomers
measure: Time to Eligibility for Home Discharge
timeFrame: Expected up to 24 hrs post surgery
measure: Time to First Spontaneous Urine Voiding
timeFrame: Expected up to 24 hrs post surgery
measure: Time to First Post-operative Analgesia
timeFrame: Expected up to 24 hrs post surgery
measure: Time to Administration of Rescue Anaesthesia or Rescue Analgesia
timeFrame: Expected up to 24 hrs post surgery
measure: Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma
timeFrame: at pre-dose, 5, 10, 30 and 60 min after spinal puncture
measure: Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine
timeFrame: at the time of first urine voiding post surgery
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 6 +/- 1 after spinal puncture
measure: Transient Neurological Symptoms (TNS)
timeFrame: Up to Day 6 +/- 1 after spinal puncture
measure: Pain Assessment at the Site of Injection and at the Site of Surgery
timeFrame: Up to Day 6 +/- 1 after spinal puncture
measure: Heart Rate
timeFrame: Expected up to 24 hrs post surgery
measure: Blood Pressure
timeFrame: Expected up to 24 hrs post surgery
measure: SpO2
timeFrame: Expected up to 24 hrs post surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Stefano Bonarelli
Study officials:
affiliation: Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS
name: Stefano MD Bonarelli
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.