NCT07092891

Brief Summary

Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary. Emerging non-invasive monitoring technologies offer promising alternatives for the early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases due to sympathetic nerve blockade-induced vasodilation.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

July 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

July 15, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

Brachial Plexus BlocksRegional Anaesthesia

Outcome Measures

Primary Outcomes (2)

  • Change in Skin Temperature (°C) Measured by Infrared Thermography From Baseline to 10 Minutes Post-block.

    Mean change in skin temperature on the operative limb captured using infrared thermography at defined time points.

    Baseline, 5, and 10 minutes post-injection

  • Change in Perfusion Index From Baseline to 10 Minutes Post-block

    PI measured via pulse oximeter; change calculated as ratio to baseline values.

    Baseline, 5, and 10 minutes post-injection

Secondary Outcomes (1)

  • Correlation Between Changes in Skin Temperature and Perfusion Index With Sensory and Motor Block Scores at 20 Minutes

    20 minutes post-injection

Study Arms (1)

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

EXPERIMENTAL

Participants will receive an ultrasound-guided supraclavicular brachial plexus block using 30 mL of 0.5% bupivacaine for upper limb surgery. Infrared thermography and perfusion index measurements will be recorded at baseline, and at 5, 10, and 15 minutes post-block to detect early physiological changes. Clinical assessment of sensory and motor block will be performed at 20 minutes post-injection using standardized testing. The goal is to evaluate the predictive accuracy of these non-invasive measures in detecting block success or failure.

Procedure: Ultrasound-Guided Supraclavicular BlockDrug: Bupivacaine Hydrochloride 0.5 % Injectable SolutionDevice: UltrasoundDevice: Infrared Thermography CameraDevice: Pulse Oximeter

Interventions

Ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear ultrasound probe-real-time visualization of the brachial plexus for precise anesthetic delivery.

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

30 mL used for supraclavicular brachial plexus block

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

Imaging for block placement

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

Skin temperature monitoring

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

Perfusion Index monitoring

Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-70 years
  • ASA Physical Status I-III

You may not qualify if:

  • General
  • Coagulopathy
  • Allergy to local anesthetics
  • Special
  • Neurological deficits in the affected limb
  • Peripheral vascular disease or Raynaud's phenomenon
  • Infections or skin lesions at the site of injection
  • Use of a tourniquet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gamal M, Hasanin A, Adly N, Mostafa M, Yonis AM, Rady A, Abdallah NM, Ibrahim M, Elsayad M. Thermal Imaging to Predict Failed Supraclavicular Brachial Plexus Block: A Prospective Observational Study. Local Reg Anesth. 2023 Jun 9;16:71-80. doi: 10.2147/LRA.S406057. eCollection 2023.

    PMID: 37323293BACKGROUND
  • Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.

    PMID: 28854539BACKGROUND

MeSH Terms

Interventions

BupivacaineUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Assiut University hospital

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 30, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07