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Age: 18Years +
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Healthy Volunteers
ID07620002

Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery: Prospective Comparison Trial

Led by Carmel Medical Center · Updated on 2026-06-02

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether a unilateral brachial plexus block (BPB), used in upper extremity surgery, causes measurable differences in autonomic nervous system activity between the two arms. This observational study evaluates the lateralized autonomic modulation by monitoring nociception levels (NoL) in both hands during standardized stimuli under general anesthesia. The goal is to find objective physiological markers for regional anesthesia effectiveness, beyond traditional sensory and motor tests, especially when patients are sedated or anesthetized. Participants will receive a single-shot ultrasound-guided BPB using 10 mL of 0.5% bupivacaine alongside general anesthesia. General anesthesia includes midazolam, fentanyl, propofol, rocuronium, and maintenance with inhalational anesthetics plus continuous remifentanil infusion adjusted for hemodynamic response. Nociception levels will be recorded bilaterally during local anesthetic injection, endotracheal intubation, and nasogastric tube placement using a non-invasive NoL monitoring device attached to the index fingers. During the approximately 5-hour study, participants undergo thorough monitoring with standard anesthesia assessments and continuous NoL measurements. Postoperative pain intensity and analgesic consumption will also be recorded to analyze correlations with NoL values. Safety will be monitored through standard clinical evaluations and adverse event reporting. The primary outcome is the difference in NoL values between the blocked and non-blocked arms during specific stimuli. Secondary outcomes include correlations between NoL measurements and postoperative pain and analgesic use.

CONDITIONS

Brief Title

Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18
  • Scheduled for upper extremity surgery
  • Signed and dated informed consent forms provided
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Known allergy to bupivacaine or anesthetic medicines including midazolam, fentanyl, propofol, rocuronium, remifentanil, or sevoflurane
  • Known bleeding disorders or coagulopathy
  • Thrombocytopenia
  • Abnormal blood clotting tests in the previous week
  • Current participation in another study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 day prior to surgery

Participants undergo pre-anesthetic evaluation and eligibility assessment for general and regional anesthesia before the procedure.

1 visit (in-person)

Treatment

Duration - Approximately 5 hours

Participants receive a single ultrasound-guided brachial plexus block using local anesthetics and undergo general anesthesia with monitoring of nociception levels during surgery.

1 intraoperative visit including anesthesia induction, surgery, and monitoring

Post-operative Follow-up

Duration - Up to discharge from post-anesthetic care unit (within same day)

Participants are assessed for block efficacy, postoperative pain using visual analog scale, analgesic consumption, and safety monitoring in the post-anesthetic care unit.

1 post-operative visit (in-person)

Trial Site Locations

Total: 1 location

1

Carmel medical center

Haifa, Israel, 3436212

Actively Recruiting

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Research Team

M

Michael Grach, DR.

D

Dana Kosh, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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