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

April 26, 2021 updated by: Sintetica SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Stefano Bonarelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • Ampres 1%
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
Other Names:
  • Ampres 1%
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
Other Names:
  • Ampres 1%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Up to 5 hours after regression of two dermatomers

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 40 min after spinal injection
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
Up to 40 min after spinal injection
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
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
Up to 1 h and 40 min after readiness for surgery
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
Up to 5 h after regression of two dermatomers
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)
Up to 5 h after regression of two dermatomers
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
Up to 5 h after regression of two dermatomers
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
Up to 5 h after regression of two dermatomers
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
Up to 1 h and 40 min after readiness for surgery
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)
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 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
Up to 5 h after regression of two dermatomers
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
Expected up to 24 hrs post surgery
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
Expected up to 24 hrs post surgery
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
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
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
at pre-dose, 5, 10, 30 and 60 min after spinal puncture
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
at the time of first urine voiding post surgery
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
Up to Day 6 +/- 1 after spinal puncture
Transient Neurological Symptoms (TNS)
Time Frame: Up to Day 6 +/- 1 after spinal puncture
Up to Day 6 +/- 1 after spinal puncture
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
Up to Day 6 +/- 1 after spinal puncture
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
Expected up to 24 hrs post surgery
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
Expected up to 24 hrs post surgery
SpO2
Time Frame: Expected up to 24 hrs post surgery

The following normal ranges SpO2 parameters will be used:

Peripheral Oxygen Saturation: ≥ 95%
Expected up to 24 hrs post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sintetica SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cross S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefano MD Bonarelli, Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHL.1/02-2014
  • 2014-003778-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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