Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery

NCT07620002 | Recruiting DMC

• 1 other identifier: 0110-22-CMC
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brachial Plexus Blockade

Keywords

brachial plexus block upper extremity; nociception level

Outcome Measures

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).

  five hours

Secondary Outcomes (2)

• Perioperative pain Assessments and correlations between NoL and VAS values

  five hours

• Perioperative correlations between total analgesic consumption with VAS and with NoL values

  Five hours

Study Arms (1)

patient both arms: one operated under brachial plexus block, other serves only as control;

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

forty five patients over 18 years old meeting inclusion criteria

You may qualify if:

• Age \>18
• Upper extremity surgery
• Provision of signed and dated informed consent forms

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel medical center

Haifa, 3436212, Israel

RECRUITING

Central Study Contacts

Michael Grach, DR.

CONTACT

+972506265753; Grachm@gmail.com

Dana Kosh, Dr.

CONTACT

972-48250785; danak@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: June 2, 2026
• Study Start: March 28, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-03

Locations

IL (1)