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

Sintetica SA45 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Short Duration Lower Limb Surgery Via Spinal Anaesthesia

Interventions

Chloroprocaine HCl 1%DRUG

Intrathecal Route

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stefano Bonarelli

Bologna, Italy

Outcomes

Primary Outcomes

Time to Regression of Spinal Block

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 frame: Up to 5 hours after regression of two dermatomers

Secondary Outcomes

Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)

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 frame: Up to 40 min after spinal injection

Time to Onset of Motor Block

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

Time frame: Up to 40 min after spinal injection

Time to Readiness for Surgery

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 frame: Up to 40 min after spinal injection

Time to Regression of Spinal Block

Time frame: Up to 1 h and 40 min after readiness for surgery

Time to Resolution of Sensory Block to S1(Min)

Data from ClinicalTrials.gov

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

Time frame: Up to 5 h after regression of two dermatomers

Time to Resolution of Motor Block

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 frame: Up to 5 h after regression of two dermatomers

Time to Unassisted Ambulation

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

Time frame: Up to 5 h after regression of two dermatomers

Sensory Block Metameric Level

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

Time frame: Up to 5 h after regression of two dermatomers

Maximum Level of Sensory Block

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

Time frame: Up to 1 h and 40 min after readiness for surgery

Time to Maximum Level of Sensory Block

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 frame: Up to 1 h and 40 min after readiness for surgery

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

Time frame: Up to 5 h after regression of two dermatomers

Time to Eligibility for Home Discharge

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 frame: Expected up to 24 hrs post surgery

Time to First Spontaneous Urine Voiding

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

Time frame: Expected up to 24 hrs post surgery

Time to First Post-operative Analgesia

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

Time frame: Expected up to 24 hrs post surgery

Time to Administration of Rescue Anaesthesia or Rescue Analgesia

Time frame: Expected up to 24 hrs post surgery

Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma

Time frame: at pre-dose, 5, 10, 30 and 60 min after spinal puncture

Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine

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

Time frame: at the time of first urine voiding post surgery

Treatment-emergent Adverse Events (TEAEs)

All AEs occurring or worsening after the dose of IMP

Time frame: Up to Day 6 +/- 1 after spinal puncture

Transient Neurological Symptoms (TNS)

Time frame: Up to Day 6 +/- 1 after spinal puncture

Pain Assessment at the Site of Injection and at the Site of Surgery

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

Time frame: Up to Day 6 +/- 1 after spinal puncture

Heart Rate

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

Time frame: Expected up to 24 hrs post surgery

Blood Pressure

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

Time frame: Expected up to 24 hrs post surgery

SpO2

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

Time frame: Expected up to 24 hrs post surgery