Phase 2
N=45
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02481505 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Time to Regression of Spinal Block — 40.8; 39.4; 41.5 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Chloroprocaine HCl 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sintetica SA
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Regression of Spinal Block |
1.761; 2.127; 2.229 | — |
| SECONDARY Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) |
5.4; 6.6; 4.8 | — |
| SECONDARY Time to Onset of Motor Block |
6.3; 6; 4.4 | — |
| SECONDARY Time to Readiness for Surgery |
8; 7.9; 5.3 | — |
| SECONDARY Time to Regression of Spinal Block |
1.761; 2.127; 2.229 | — |
| SECONDARY Time to Resolution of Sensory Block to S1(Min) |
1.761; 2.127; 2.195 | — |
| SECONDARY Time to Resolution of Motor Block |
2.662; 3.361; 3.213 | — |
| SECONDARY Time to Unassisted Ambulation |
2.662; 3.361; 3.213 | — |
| SECONDARY Sensory Block Metameric Level |
0; 2; 2; 1; 0; 1 | — |
| SECONDARY Maximum Level of Sensory Block |
0; 2; 2; 1; 0; 1 | — |
| SECONDARY Time to Maximum Level of Sensory Block |
0.224; 0.235; 0.234 | — |
| SECONDARY Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block |
0.687; 0.851; 0.695 | — |
| SECONDARY Time to Eligibility for Home Discharge |
3.021; 3.545; 3.530 | — |
| SECONDARY Time to First Spontaneous Urine Voiding |
2.530; 3.361; 3.067 | — |
| SECONDARY Time to First Post-operative Analgesia |
8.186; 2.928; 2.988 | — |
| SECONDARY Time to Administration of Rescue Anaesthesia or Rescue Analgesia |
0.717; 0.315; 0 | — |
| SECONDARY Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma |
16.127; 20.411; 24.887; 41.440; 38.851; 75.833 | — |
| SECONDARY Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine |
1217.7; 1827.9; 2103.5 | — |
| SECONDARY Treatment-emergent Adverse Events (TEAEs) |
14; 13; 13; 2; 3; 3 | — |
| SECONDARY Transient Neurological Symptoms (TNS) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pain Assessment at the Site of Injection and at the Site of Surgery |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Heart Rate |
62.2; 67.5; 70.7; 63.1; 71; 71.7 | — |
| SECONDARY Blood Pressure |
120; 126; 121.6; 116.9; 127.9; 125.5 | — |
| SECONDARY SpO2 |
99.7; 99.13; 98.53; 99.4; 99.13; 98.53 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02481505). 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.