Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCarmel Medical Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

45 Participants
are grouped into 1 trial group
Group A: patient both arms: one operated under brachial plexus block, other serves only as control;

Trial outcomes

Primary outcomes

1

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).

Time frame
five hours

Secondary outcomes

1

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).

Time frame
five hours
2

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)

Time frame
Five hours

Other outcomes

Sponsors and contacts

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