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Completed

NCT Number: NCT02481505

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

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.

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Key information

Conditions

Short Duration Lower Limb Surgery Via Spinal Anaesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stefano Bonarelli

Bologna, 40136, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
  • ASA physical status: I-II
  • 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

  • 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
  • ASA physical status: III-V
  • Further anaesthesia: patients expected to require further anaesthesia
  • Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major anaesthetics
  • 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.
  • 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
  • Drug, alcohol: history of drug or alcohol abuse
  • Blood donation: blood donations in the 3 months before this study
  • Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
  • 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.

Treatment and study plan

Chloroprocaine HCl 1%

Drug

Intrathecal Route

Other names: Ampres 1%

Primary outcomes

  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 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 outcomes

  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 (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.

  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

  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 (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)

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

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

  17. 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

  18. 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

  19. Transient Neurological Symptoms (TNS)

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

  20. 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

  21. 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

  22. 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

  23. SpO2

    Time frame: Expected up to 24 hrs post surgery

    The following normal ranges SpO2 parameters will be used:

    Peripheral Oxygen Saturation: ≥ 95%

Sponsors and collaborators

Lead sponsor

Sintetica SA

Industry

Collaborators

  • Cross S.A.

Registry information

Official study title

Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2015
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.