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

Phase 2

Completed

• Conditions: Short Duration Lower Limb Surgery Via Spinal Anaesthesia
• Interventions: Drug: Chloroprocaine HCl 1%

• Registration Number: NCT02481505
• Lead Sponsor: Sintetica SA

Brief Summary

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.

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)

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-12-20
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Results First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 mL Chloroprocaine HCl 1%	Chloroprocaine HCl 1%	Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)
4 mL Chloroprocaine HCl 1%	Chloroprocaine HCl 1%	Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)
5 mL Chloroprocaine HCl 1%	Chloroprocaine HCl 1%	Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)

Primary Outcome Measures

Name	Time	Method
Time to Regression of Spinal Block	Up to 5 hours after regression of two dermatomers	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)

Secondary Outcome Measures

Name	Time	Method
Time to Eligibility for Home Discharge	Expected up to 24 hrs post surgery	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
Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine	at the time of first urine voiding post surgery	Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
SpO2	Expected up to 24 hrs post surgery	The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Time to Readiness for Surgery	Up to 40 min after spinal injection	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 to Administration of Rescue Anaesthesia or Rescue Analgesia	Expected up to 24 hrs post surgery
Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma	at pre-dose, 5, 10, 30 and 60 min after spinal puncture
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)	Up to 40 min after spinal injection	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 to Onset of Motor Block	Up to 40 min after spinal injection	Time period from spinal injection (time 0 h) to achievement of motor block
Time to Resolution of Sensory Block to S1(Min)	Up to 5 h after regression of two dermatomers	Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1
Time to Resolution of Motor Block	Up to 5 h after regression of two dermatomers	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)
Sensory Block Metameric Level	Up to 5 h after regression of two dermatomers	Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1
Time to First Post-operative Analgesia	Expected up to 24 hrs post surgery	Time from spinal injection (time 0 h) to first post-operative analgesia
Time to Regression of Spinal Block	Up to 1 h and 40 min after readiness for surgery
Time to Unassisted Ambulation	Up to 5 h after regression of two dermatomers	Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted
Maximum Level of Sensory Block	Up to 1 h and 40 min after readiness for surgery	Maximum metameric level of sensory block (decreased or absent sensation) achieved
Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block	Up to 5 h after regression of two dermatomers	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 to Maximum Level of Sensory Block	Up to 1 h and 40 min after readiness for surgery	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 to First Spontaneous Urine Voiding	Expected up to 24 hrs post surgery	Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted
Treatment-emergent Adverse Events (TEAEs)	Up to Day 6 +/- 1 after spinal puncture	All AEs occurring or worsening after the dose of IMP
Transient Neurological Symptoms (TNS)	Up to Day 6 +/- 1 after spinal puncture
Pain Assessment at the Site of Injection and at the Site of Surgery	Up to Day 6 +/- 1 after spinal puncture	Number of patients with pain at the site of injection and at the site of surgery
Heart Rate	Expected up to 24 hrs post surgery	The following normal ranges Heart Rate parameters will be used: 50-90 beats/min
Blood Pressure	Expected up to 24 hrs post surgery	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

Trial Locations

Locations (1)

Stefano Bonarelli; 🇮🇹 Bologna, Italy