Chloroprocaine 1 % - Spinal Block

Condition(s) targeted: Short Duration Lower Limb Surgery Via Spinal Anaesthesia

Intervention: Chloroprocaine HCl 1% (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sintetica SA

Official(s) and/or principal investigator(s):
Stefano MD Bonarelli, Principal Investigator, Affiliation: Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS via G.C. Pupilli 1 - 40136 Bologna, Italy

Overall contact:
Elisabetta Donati, Phone: +41(0)91 640 42 50, Ext: 0041, Email: edonati@sintetica.com

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Primary outcome: Time to regression of spinal block

Secondary outcome:

Time to onset of sensory block (corresponding to readiness for surgery)

Time to onset of motor block

Time to readiness for surgery

Time to regression of spinal block

Time to resolution of sensory block to S1(min)

Time to resolution of motor block

Time to unassisted ambulation

Sensory block metameric level

Maximum level of sensory block

Time to maximum level of sensory block

Time to regression of two dermatomers with respect to the maximum level of sensory block

Time to eligibility for home discharge

Time to first spontaneous urine voiding

Time to first post-operative analgesia

Time to administration of rescue anaesthesia or rescue analgesia

Concentration of chloroprocaine in plasma

Concentration of 2-chloro-4-aminobenzoic acid (CABA) in plasma

Excretion of 2-chloro-4-aminobenzoic acid (CABA) in urine

Treatment-emergent adverse events (TEAEs)

Transient Neurological symptoms (TNS)

Pain assessment at the site of injection and at the site of surgery

Heart rate

Blood pressure

SpO2

ECG

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)

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Elisabetta Donati, Phone: +41(0)91 640 42 50, Ext: 0041, Email: edonati@sintetica.com

Stefano Bonarelli, Bologna 40136, Italy; Recruiting

Starting date: June 2015
Last updated: July 22, 2015