N/A
Completed N=394
Observational Study on 2-chloroprocaine Hydrochloride 1%
Neurological Complication, in Particular TNS or CES
Source: ClinicalTrials.gov NCT02067806 ↗
Enrolled (actual)
394
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Adverse Events — 9; 5 participants
Summary
The present study aims to evaluate the relationship between spinal block with 1% solution of 2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
9; 5 | — |
| PRIMARY Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours |
4; 3; 1; 1 | — |
| PRIMARY Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days |
3; 1; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Male/female adult patients
- Ability to comprehend the full nature and purpose of the study
- Ability to co-operate with the Investigator and to comply with the requirements of the entire study
- Signed written informed consent of the patients prior to inclusion in the observational study. The signature has to be done before the elective surgery.
- Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.
Exclusion Criteria
- Hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anaesthetics or to any of the excipients (Hydrochloric acid 1N for pH adjustment, Sodium chloride, Water for injection)
- General and specific contra-indications to spinal anaesthesia regardless of the local anaesthetic used, should be taken into account (e.g. decompensated cardiac insufficiency, hypovolemic shock….)
- Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area)
- Serious problems with cardiac conduction,
- Severe anaemia,
- It is also necessary to take into consideration general and specific contraindications for the technique of spinal anaesthesia = intrathecal anaesthesia
Data sourced from ClinicalTrials.gov (NCT02067806). 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. Informational only — not medical advice.