Clinical trial NCT03138577: Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Block
Official title: Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery of Right Upper Extremity
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A modified "3+3" dose escalation design, modeled after Phase I dose-finding trials, was used to define the dose response curve for local anesthetic volume in the supraclavicular block and resulting hemidiaphragmatic paresis in patients undergoing right upper extremity surgery with supraclavicular block as the primary anesthetic. Possible dosing levels of 5, 10, 15, 20, 25, 30, 35 and 40 mL of local anesthetic were pre-specified with a cohort of three subjects per dose. Diaphragm function was determined by a blinded assessor with M-mode tracings of the right diaphragm before and after supraclavicular block. Secondary objectives included the assessment of respiratory function via negative inspiratory force, oxygen saturation and subjective dyspnea, as well as the extent of sensory and motor blockade.
Primary purpose: TREATMENT

Brief summary: This clinical trial is for subjects undergoing right upper extremity surgery. The aim of the study is to investigate the dose-response relationship between local anesthetic volume and ipsilateral hemidiaphragmatic paresis (HDP) in patients getting ultrasound-guided supraclavicular brachial plexus blocks in a blinded, prospective trial.

Detailed description: With traditional landmark-based or nerve-stimulator techniques, the incidence of HDP following supraclavicular blocks is approximately 50-67%. Ultrasound-guided techniques are thought to enhance precision while reducing the volume of anesthetic used, but even then HDP incidence is nearly 60%. To date, no trials have studied the dose-response relationship between local anesthetic volume and degree of HDP.

Patient Selection

30 eligible patients undergoing right upper extremity surgery and eligible for supraclavicular blocks will be recruited at NewYork-Presbyterian/Weill Cornell Medical Center.

Evaluation of HDP

Baseline M-mode recordings of diaphragm function will be made by an anesthesiologist. Patients will perform "voluntary sniff" (VS) tests, or forceful nasal inhales, immediately preceding the brachial plexus blockade, and again at 15 minutes and 30 minutes after the block.

Diaphragmatic excursion from baseline will be measured in centimeters; three measurements will be made and averaged. Hemidiaphragmatic paresis will be defined as greater than or equal to 60% reduction in diaphragmatic excursion, no movement, or paradoxical movement in the VS test.

Evaluation of Pulmonary Function

A bedside negative inspiratory force (NIF) meter will be used to measure negative inspiratory force prior to the block and 30 minutes after the block.

Evaluation of Supraclavicular Block

At the 15- and 30-minute marks, the investigators will assess sensory blockade and motor block in the axial, musculocutaneous, radial, median, and ulnar distributions. Both will be judged on 3-point scales. The investigators will also apply a 0-10 point verbal rating scale to assess dyspnea at 30 minutes. Oxygen saturation will be measured off of supplemental oxygen before the block and 30 minutes after the block.

Following the assessments, patients will have surgery using brachial plexus blockade as the primary anesthetic.

Eligibility criteria: Inclusion Criteria:

* Undergoing right upper extremity surgery with supraclavicular block as the primary anesthetic
* Age greater than or equal to 18 years of age
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Able to give informed consent

Exclusion Criteria:

* Patient refusal for supraclavicular block
* Inability to give informed consent
* Allergy to local anesthetics
* Hemidiaphragmatic dysfunction, suspected or known pulmonary disease
* Neuromuscular disease
* Obstructive or restrictive pulmonary disease
* Medical or anatomic contraindication to supraclavicular blockade as judged by clinician
* Pregnancy

Primary outcomes:
measure: Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block
timeFrame: 15 minutes
measure: Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Negative Inspiratory Force (NIF) at 30 Minutes
timeFrame: 30 minutes
measure: Dose Response Curve for Motor and Sensory Block 15 Minutes After Block
timeFrame: 15 minutes
measure: Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block
timeFrame: 30 minutes
measure: Change in Room Air Oxygen Saturation at 30 Minutes.
timeFrame: 30 minutes
measure: Subjective Dyspnea 30 Minutes After Block
timeFrame: 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: WCMC, NYP
name: Tiffany Tedore, MD
role: PRINCIPAL_INVESTIGATOR
References:
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