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Recruiting Observational

Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery

NCT07620002 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2023-03-28
Last updated
2026-06-02

Condition(s) studied

Brachial Plexus Blockade

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age \>18 * Upper extremity surgery * Provision of signed and dated informed consent forms Exclusion Criteria: * Pregnant women * Known allergic reaction to bupivacaine or other anesthetic medicine: Midazolam, Fentanyl, Propofol, Rocuronium, Remifentanil, Sevoflurane) * Known coagulopathy resulting in bleeding tendency * Thrombocytopenia * Abnormal laboratory coagulation tests in the previous week = Anticoagulation therapy Participation in other study

Primary outcome measure(s)

  • Comparison ipsilateral and contralateral NoL values in both arms — five hours
    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).

Trial sites (1)

FacilityCityRegionStatus
Carmel medical center Haifa Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07620002 on ClinicalTrials.gov ↗ ← All trials in Israel