Short duration (less than 40 min) lower limb surgery via spinal anaesthesia MedDRA version: 17.1 Level: PT Classification code 10041536 Term: Spinal anaesthesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Decelex
Product Name: Decelex (chloroprocaine HCl 1%[10 mg/mL])
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CHLOROPROCAINE HYDROCHLORIDE
CAS Number: 3
Sponsors
Sintetica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex, age and surgery: male/female patients, 18-80 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-III 4. Informed consent: signed written informed consent before inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
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: IV-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to 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, in terms of time to complete regression of spinal block ;Secondary Objective: To evaluate the efficacy of three Chloroprocaine HCl 1% doses in terms of Time to onset of sensory block and motor block, Time to readiness for surgery, Time to resolution of motor block and sensory block to S1, Time to unassisted ambulation, Sensory block metameric levels during the block, 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 first spontaneous urine voiding, Time to administration of rescue anaesthesia or rescue analgesia, Time to first post-operative analgesia, Time to eligibility for home discharge, proportion of patients achieving effective anaesthesia, quality of spinal block; concentration of chloroprocaine and its metabolite 2-chloro-4-aminobenzoic acid (CABA) in plasma; excretion of the CABA in urine ; safety and tolerability of the administered Chloroprocaine HCl 1% doses;Primary end point(s): To evaluate the efficacy of the three Chloroprocaine HCl 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);Timepoint(s) of evaluation of this end point: The evolution of spinal block will be evaluated before, during and after the surgery. Time to regression of spinal block is defined as the time when Bromage score returns to 0 and sensitive level returns to S2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (30, 40 and 50 mg) in terms of Time to onset of sensory block, Time to onset of motor block, Time to readiness for surgery, Time to resolution of motor block, Time to unassisted ambulation, Time to resolution of sensory block to S1, Sensory block metameric levels during the block, 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 first spontaneous urine voiding, Time to administration of rescue anaesthesia or rescue analgesia, Time to first post-operative analgesia, Time to eligibility for home discharge, proportion of patients achieving an effective anaesthesia, quality of spinal block; To assess the concentration of chloroprocaine and its metabolite 2-chloro-4-aminobenzoic acid (CABA) in plasma; To assess the excretion of CABA in urine; To investigate the safety and tolerability of the administered Chloroprocaine HCl 1% doses. ;Timepoint(s) of evaluation of this end point: The evolution of 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. After that, sensory and motor block assessments will be repeated every 30 min until regression of spinal block and complete regression of sensory block to S1 (if compatible with surgical procedure). Blood samples for PK analysis will be collected at baseline and at 5 10, 30 and 60 min after spinal puncture. Urine will be collected at the time of spontaneous voiding. Safety and tolerability will be assessed throughout the study. | — |
Countries
Italy
Contacts
Public ContactStudy Management
CROSS S.A.
Outcome results
None listed