Spinal anaesthesia Surgery Surgical pain relief
Conditions
Interventions
Active constituent: 2-chloroprocaine hydrochloride at a concentration of 1%
Chemical name and formula: N-(2-diethylaminoethyl)-4-amino-2-chlorobenzoate C13H20N2O-HCl
MW: 307.22
Pharmaceutical form: in
Sponsors
Sintetica S.A. (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/female adolescent patients scheduled for short duration (less than 40 minutes) lower limb surgery under spinal anaesthesia 2. Aged 12 to less than 18 years old 3. Body mass index (BMI) between 18 and 32 kg/m2 4. American Society of Anesthesiologists (ASA) physical status I - II 5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects 6. Ability to co-operate with the Investigator and to comply with the requirements of the entire study 7. Signed written informed consent of the patients prior to inclusion in the study; patient consent has to be expressed prior to the consent of parents/legal guardian 8. Signed written informed consent of parents/legal guardian prior to inclusion in the study
Exclusion criteria
Exclusion criteria: 1. Lactating females 2. Pregnancy: females who will result positive to the pregnancy test performed at the screening visit 3. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study 4. Contraindications to spinal anaesthesia 5. History of neuromuscular diseases to the lower extremities 6. ASA physical status III - V 7. Signed written informed consent of parents/legal guardian prior to the patients consent 8. Patients requiring further anaesthesia (i.e. iv propofol) 9. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and major anaesthetics 10. Diseases: ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, contraindications to spinal anaesthesia 11. Drug and alcohol: history of drug abuse, history of alcohol abuse, therapeutic use of opioids 12. Assumption of any investigational medicinal product within the previous 60 days before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the efficacy of three 2-chloroprocaine dosages (T1 0.206 mg/cm, T2 0.235 mg/cm, T3 0.265 mg/cm) in terms of proportions of subjects who need additional analgesia or rescue general anaesthesia during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the following parameters for the three doses of 1% 2-chloroprocaine: 1. Time to the first rescue dose during surgery time 2. Time to onset of motor block; the level of motor block is assessed by using the modified Bromage's scale 3. Maximum level of sensory block 4. Time to resolution (Offset) of sensory block to S2 5. Time to resolution of motor block (Bromage score = 0) 6. Time to the first rescue dose after surgery time 7. Time to unassisted ambulation 8. Presence of urinary retention 9. Time to eligibility for home discharge (for day surgery only) Sensory block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. The quality of spinal block will be verified according to the need for supplementary intravenous analgesics and sedation as follows: 1. Adequate spinal block = neither sedation nor analgesics required to complete surgery 2. Inadequate spinal block = need for additional analgesia (2 µg/Kg mg iv bolus of fentanyl) required to complete surgery 3. Failed spinal block = general anaesthesia required to complete surgery (propofol iv) Duration of surgery will also be recorded. Motor block will be verified using a modified Bromage scale (0 = no block; 1 = hip blocked; 2 = hip and knee blocked; 3 = hip, knee and ankle blocked). | — |
Countries
Switzerland
Outcome results
None listed