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Chloroprocaine 1 % - Spinal Block

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ClinicalTrials.gov Identifier: NCT02481505
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
Cross S.A.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Short Duration Lower Limb Surgery Via Spinal Anaesthesia Drug: Chloroprocaine HCl 1% Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients
Study Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3 mL Chloroprocaine HCl 1%
Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)
Drug: Chloroprocaine HCl 1%
Intrathecal Route

Experimental: 4 mL Chloroprocaine HCl 1%
Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)
Drug: Chloroprocaine HCl 1%
Intrathecal Route

Experimental: 5 mL Chloroprocaine HCl 1%
Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)
Drug: Chloroprocaine HCl 1%
Intrathecal Route




Primary Outcome Measures :
  1. Time to regression of spinal block [ Time Frame: 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 SO mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)


Secondary Outcome Measures :
  1. Time to onset of sensory block (corresponding to readiness for surgery) [ Time Frame: Up to 40 min after spinal injection ]
    Time period from spinal injection (Tsp; time 0 h) to achievement of sensory block

  2. Time to onset of motor block [ Time Frame: Up to 40 min after spinal injection ]
    Time period from spinal injection (time 0 h) to achievement of motor block

  3. Time to readiness for surgery [ Time Frame: 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

  4. Time to regression of spinal block [ Time Frame: Up to 1 h and 40 min after readiness for surgery ]
    Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1

  5. Time to resolution of sensory block to S1(min) [ Time Frame: 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

  6. Time to resolution of motor block [ Time Frame: 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

  7. Time to unassisted ambulation [ Time Frame: 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

  8. Sensory block metameric level [ Time Frame: 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

  9. Maximum level of sensory block [ Time Frame: Up to 1 h and 40 min after readiness for surgery ]
    Maximum metameric level of sensory block (decreased or absent sensation) achieved

  10. Time to maximum level of sensory block [ Time Frame: 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)

  11. Time to regression of two dermatomers with respect to the maximum level of sensory block [ Time Frame: 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

  12. Time to eligibility for home discharge [ Time Frame: 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

  13. Time to first spontaneous urine voiding [ Time Frame: 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

  14. Time to first post-operative analgesia [ Time Frame: Expected up to 24 hrs post surgery ]
    Time from spinal injection (time 0 h) to first post-operative analgesia

  15. Time to administration of rescue anaesthesia or rescue analgesia [ Time Frame: Expected up to 24 hrs post surgery ]
  16. Concentration of chloroprocaine in plasma [ Time Frame: at pre-dose, 5, 10, 30 and 60min after spinal puncture ]
    Time period from time 0 to 60 min after spinal puncture

  17. Concentration of 2-chloro-4-aminobenzoic acid (CABA) in plasma [ Time Frame: at pre-dose, 5, 10, 30 and 60 min after spinal puncture ]
    Time period from time 0 to 60 min after spinal puncture

  18. Excretion of 2-chloro-4-aminobenzoic acid (CABA) in urine [ Time Frame: 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

  19. Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 6 +/- 1 after spinal puncture ]
    All AEs occurring or worsening after the dose of IMP

  20. Transient Neurological symptoms (TNS) [ Time Frame: Up to Day 6 +/- 1 after spinal puncture ]
    Number of patients with TNS

  21. Pain assessment at the site of injection and at the site of surgery [ Time Frame: Up to Day 6 +/- 1 after spinal puncture ]
    Number of patients with pain at the site of injection and at the site of surgery

  22. Heart rate [ Time Frame: Expected up to 24 hrs post surgery ]

    The following normal ranges Heart Rate parameters will be used:

    50-90 beats/min


  23. Blood pressure [ Time Frame: 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


  24. SpO2 [ Time Frame: Expected up to 24 hrs post surgery ]

    The following normal ranges SpO2 parameters will be used:

    Peripheral Oxygen Saturation: ≥ 95%


  25. ECG [ Time Frame: Expected up to 24 hrs post surgery ]

    The following normal ranges ECG parameters will be used:

    Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481505


Locations
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Italy
Stefano Bonarelli
Bologna, Italy, 40136
Sponsors and Collaborators
Sintetica SA
Cross S.A.
Investigators
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Principal Investigator: Stefano MD Bonarelli Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS via G.C. Pupilli 1 - 40136 Bologna, Italy

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Responsible Party: Sintetica SA
ClinicalTrials.gov Identifier: NCT02481505     History of Changes
Other Study ID Numbers: CHL.1/02-2014
2014-003778-17 ( EudraCT Number )
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents