Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Block

Phase 4

Completed

• Conditions: Surgery of Right Upper Extremity
• Interventions: Diagnostic Test: Ultrasound Imaging; Drug: Supraclavicular Block; Other: Bedside Negative Inspiratory Force Meter

• Registration Number: NCT03138577
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2018-02-12
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-04
• Results First Submitted: 2020-04-29
• Results First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Results First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Cohort 7	Ultrasound Imaging	5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 7	Supraclavicular Block	5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 7	Bedside Negative Inspiratory Force Meter	5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 6	Ultrasound Imaging	10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 6	Supraclavicular Block	10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 6	Bedside Negative Inspiratory Force Meter	10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 5	Ultrasound Imaging	15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 5	Supraclavicular Block	15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 5	Bedside Negative Inspiratory Force Meter	15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 4	Ultrasound Imaging	20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 4	Supraclavicular Block	20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 4	Bedside Negative Inspiratory Force Meter	20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 3	Ultrasound Imaging	Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 3	Supraclavicular Block	Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 3	Bedside Negative Inspiratory Force Meter	Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 2	Ultrasound Imaging	30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 2	Supraclavicular Block	30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 2	Bedside Negative Inspiratory Force Meter	30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 1	Ultrasound Imaging	35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 1	Supraclavicular Block	35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter
Dose Cohort 1	Bedside Negative Inspiratory Force Meter	35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block	15 minutes	Diaphragm motion was recorded during voluntary sniffing fifteen minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block	30 minutes	Diaphragm motion was recorded during voluntary sniffing 30 minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.

Secondary Outcome Measures

Name	Time	Method
Subjective Dyspnea 30 Minutes After Block	30 minutes	30 minutes after the block, patients were asked to rate any symptoms of dyspnea on a scale of 0 (no trouble breathing) to 10 (extreme trouble breathing).
Change in Negative Inspiratory Force (NIF) at 30 Minutes	30 minutes	The change of the absolute value of NIF from the baseline measurement to that at 30 minutes after the block
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block	15 minutes	As described in the protocol, each subject's block was assessed via motor and sensory exam at 15 minutes and given a score (0-20), with 20 being a perfect block and any score less than 10 indicating an ineffective block. A dose response curve was generated for block score with different volumes of local anesthetic administered.
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block	30 minutes	As described in the protocol, each subject's block was assessed via motor and sensory exam at 30 minutes and given a score (0-20), with 20 being a perfect block and any score less than 10 indicating an ineffective block. A dose response curve was generated for block score with different volumes of local anesthetic administered.
Change in Room Air Oxygen Saturation at 30 Minutes.	30 minutes	The change in room air oxygen saturation from baseline to 30 minutes after the block was calculated.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States