About this trial
The present prospective within-subject observational study will evaluate whether unilateral brachial plexus block (BPB) induces measurable lateralized autonomic modulation, assesses using bilateral Nociception Level (NoL) monitoring during standardized intraoperative stimuli under general anesthesia. Regional anesthesia efficacy is traditionally assessed through sensory and motor examination. However, objective physiologic markers reflecting sympathetic modulation remain limited. Forty five adults undergoing upper extremity surgery with BPB and general anesthesia, bilateral NoL monitoring will be performed during local anesthetic injection, endotracheal intubation, and nasogastric tube placement. The primary aim to investigate whether the brachial plexus block induces unilateral modulation of post-operative nervous system activity, assessed by inter-limb differences in NoL values during predefined nociceptive stimuli under general anesthesia. The secondary aim to evaluate the correlation between postoperative metrics, postoperative pain intensity, and analgesic consumption. From a clinical perspective, bilateral autonomic monitoring may offer a novel adjunctive method for intraoperative confirmation of block activity, particularly in sedated or anesthetized patients where traditional sensory testing is not feasible. Furthermore, inter-limb autonomic gradients could represent a future research pathway for objective assessment of regional anesthesia effectiveness beyond subjective pain scores.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18
Upper extremity surgery
Provision of signed and dated informed consent forms
Disqualifiers
Pregnant women
Known allergic reaction to bupivacaine or other anesthetic medicine: Midazolam, Fentanyl, Propofol, Rocuronium, Remifentanil, Sevoflurane)
Known coagulopathy resulting in bleeding tendency
Thrombocytopenia
Trial population
forty five patients over 18 years old meeting inclusion criteria
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Comparison ipsilateral and contralateral NoL values in both arms
Perioperative NoL score every 5 seconds (physiological parameter measurements, range 0-100) on both arms concurrently, begin before anesthesia induction, till patient will be discharged from PACU, by a non-invasive probe attached to the index finger (in both arms, the operated hand and the contralateral unoperated arm as control) using an adhesive patch. The device monitoring module model PMD-200 manufactured by Medasense (Ramat Gan, Israel).
Secondary outcomes
Perioperative pain Assessments and correlations between NoL and VAS values
Perioperative pain outcomes, VAS scores by questionnaires, range 1-10 at 3 time points: preoperative, post brachial plexus block and discharge from PACU. Correlations between VAS and NoL physiological parameter measurements, range 0-100, by a non-invasive probe attached to the index finger (in both arms, the operated hand and the contralateral unoperated arm as control) using an adhesive patch at parallel time points. Monitoring module model PMD-200 the device manufactured by Medasense (Ramat Gan, Israel).
Perioperative correlations between total analgesic consumption with VAS and with NoL values
Perioperative correlations between total analgesic consumption with VAS and with NoL values: * Remifentanil (mg) * Morphine (mg) Non-Steroidal-Anti-Inflammatory Drugs (NSAIDs) * Paracetamol (g) * Ketorolac (mg) * Dipyrone (g)
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