Phase 3
N=211
Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
Axillary Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT02385097 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Participants With Successful Block for Distal Upper Limb Surgeries — 96; 97 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chloroprocaine HCl 2% (Drug); Ropivacaine 0.75% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sintetica SA
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Block for Distal Upper Limb Surgeries |
96; 97 | — |
| SECONDARY Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) |
10; 15 | — |
| SECONDARY Time to Onset of Motor Block |
10; 10 | — |
| SECONDARY Time to Regression of Sensory Block |
68; 451 | — |
| SECONDARY Time to Regression of Motor Block |
65; 415 | — |
| SECONDARY Partecipants Received Rescue Anaesthesia or Rescue Analgesia |
9; 7 | — |
| SECONDARY Number of Subjects Who Received Post-operative Analgesia |
49; 46 | — |
| SECONDARY Time to Eligibility for Home Discharge |
161; 355.5 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
58; 76 | — |
| SECONDARY Neurological Symptoms |
8; 1; 6; 4; 8; 25 | — |
| SECONDARY Heart Rate |
73; 73.6; 72.5; 71.6; 71.5; 73 | — |
| SECONDARY Blood Pressure |
137; 136.2; 136.6; 138; 130.5; 130.1 | — |
| SECONDARY SpO2 |
97.05; 97.36; 97.47; 97.61 | — |
| SECONDARY Number of Participants With Normal Electrocardiogram (ECG) Parameters |
105; 104 | — |
Summary
The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.
Eligibility Criteria
Inclusion Criteria
- Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia
- Age: ≥ 18 years old
- Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- ASA physical status: I-III
- Informed consent: signed written informed consent before inclusion in the study
- 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 peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities
- Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement
- ASA physical status: IV-V
- Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)
- Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type 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 diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
- Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
- 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
- Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02385097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.