Nociception Level Index After Brachial Plexus Block in Upper Extremity Surgery
Official title: Nociception Level Index After Brachial Plexus Block In Upper Extremity Surgery: Prospective Comparison Trial
Run by Carmel Medical Center · NCT07620002 · Data updated 2026-11-12
This study tests whether a brachial plexus block on one arm changes nervous system activity on that side during surgery, using bilateral NoL monitoring while the patient is under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Carmel Medical Center Academic / other |
| Locations | 1 site (Haifa) |
| Status | Recruiting |
| Started | March 28, 2023 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07620002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 years undergoing upper extremity surgery who will receive a unilateral brachial plexus block with general anesthesia.
✕Probably not a fit
Patients whose block does not produce lateral autonomic differences or who do not exhibit measurable NoL changes may not experience a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, within-subject observational study investigates whether unilateral brachial plexus block modulates autonomic responses on the blocked side. Bilateral Nociception Level monitoring will be recorded during standardized intraoperative stimuli such as local anesthetic injection, endotracheal intubation, and nasogastric tube placement in adults undergoing upper extremity surgery with general anesthesia. The primary aim is to determine if the BPB induces unilateral changes in NoL values between limbs under nociceptive conditions. A secondary aim is to explore correlations with block efficacy assessed postoperatively by pain scores and analgesic consumption. The study uses ultrasound-guided single-shot blocks with 10 mL of 0.5% bupivacaine and standardized anesthesia care, including remifentanil infusion, with NoL measurements in both hands throughout the procedure.
Why it matters
Potential benefit: If successful, NoL monitoring could provide an objective marker of regional anesthesia effectiveness and help tailor perioperative pain management.
How similar studies have gone: Prior research has explored nociception monitoring and regional anesthesia effects, but lateralized NoL changes under BPB are not well established, making this approach exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Carmel medical center
Haifa, Israel Recruiting
Study contacts
- Study coordinator: Michael Grach, DR.
- Email: Grachm@gmail.com
- Phone: +972506265753
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.