Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT06300606
Brief Summary:
This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement.
Detailed Description:
Introduction: Intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation. Recently, the Nociception Level index (NOL™) providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia. While this monitoring has also been used postoperatively in awake patients, data are scarce to assess pain under locoregional anesthesia. This study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb.
Method: 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included. Exclusion criteria were emergencies, request for general anesthesia, and patients under 18 years of age. All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice. After premedication with oral hydroxyzine, locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Monitoring began as soon as the venous infusion was started, and parameters were recorded at the time of locoregional anesthesia, tourniquet inflation, surgical incision, skin closure and dressing.
Pain is also assessed using the ALGISCORE by the nurse and the numerical scale (0 to 5) and satisfaction score at the end of the procedure. The need to administer midazolam or propofol at the anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). Data were analyzed using Friedman and Mann-Whitney tests.
Study:
NCT06300606
Study Brief:
Protocol Section:
NCT06300606