Short Duration Lower Limb Surgery Via Spinal Anaesthesia Clinical Trial
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
| Verified date | April 2021 |
| Source | Sintetica SA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Stefano Bonarelli | Bologna |
| Lead Sponsor | Collaborator |
|---|---|
| Sintetica SA | Cross S.A. |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Up to 5 hours after regression of two dermatomers | |
| Secondary | 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. | Up to 40 min after spinal injection | |
| Secondary | Time to Onset of Motor Block | Time period from spinal injection (time 0 h) to achievement of motor block | Up to 40 min after spinal injection | |
| Secondary | 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 | Up to 40 min after spinal injection | |
| Secondary | Time to Regression of Spinal Block | Up to 1 h and 40 min after readiness for surgery | ||
| Secondary | Time to Resolution of Sensory Block to S1(Min) | 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 | |
| Secondary | 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) | Up to 5 h after regression of two dermatomers | |
| Secondary | Time to Unassisted Ambulation | 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 | |
| Secondary | Sensory Block Metameric Level | 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 | |
| Secondary | Maximum Level of Sensory Block | Maximum metameric level of sensory block (decreased or absent sensation) achieved | Up to 1 h and 40 min after readiness for surgery | |
| Secondary | 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) | Up to 1 h and 40 min after readiness for surgery | |
| Secondary | 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 | Up to 5 h after regression of two dermatomers | |
| Secondary | 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 | Expected up to 24 hrs post surgery | |
| Secondary | 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 | Expected up to 24 hrs post surgery | |
| Secondary | Time to First Post-operative Analgesia | Time from spinal injection (time 0 h) to first post-operative analgesia | Expected up to 24 hrs post surgery | |
| Secondary | Time to Administration of Rescue Anaesthesia or Rescue Analgesia | Expected up to 24 hrs post surgery | ||
| Secondary | Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma | at pre-dose, 5, 10, 30 and 60 min after spinal puncture | ||
| Secondary | 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 | at the time of first urine voiding post surgery | |
| Secondary | Treatment-emergent Adverse Events (TEAEs) | All AEs occurring or worsening after the dose of IMP | Up to Day 6 +/- 1 after spinal puncture | |
| Secondary | Transient Neurological Symptoms (TNS) | Up to Day 6 +/- 1 after spinal puncture | ||
| Secondary | 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 | Up to Day 6 +/- 1 after spinal puncture | |
| Secondary | Heart Rate | The following normal ranges Heart Rate parameters will be used:
50-90 beats/min |
Expected up to 24 hrs post surgery | |
| Secondary | 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 |
Expected up to 24 hrs post surgery | |
| Secondary | SpO2 | The following normal ranges SpO2 parameters will be used:
Peripheral Oxygen Saturation: = 95% |
Expected up to 24 hrs post surgery |