Trial Outcomes & Findings for Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration. (NCT NCT02481505)

Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.

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)

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.

Time period from spinal injection (time 0 h) to achievement of motor block

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

Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1

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)

Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted

Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1

Maximum metameric level of sensory block (decreased or absent sensation) achieved

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)

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

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

Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted

Time from spinal injection (time 0 h) to first post-operative analgesia

Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted

All AEs occurring or worsening after the dose of IMP

Number of patients with pain at the site of injection and at the site of surgery

The following normal ranges Heart Rate parameters will be used: 50-90 beats/min

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

The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%