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Phase 4 N=21 Single-blind Treatment

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

Surgery of Right Upper Extremity

Bottom Line

View on ClinicalTrials.gov: NCT03138577 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block — 1; 1; 1; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ultrasound Imaging (Diagnostic_test); Supraclavicular Block (Drug); Bedside Negative Inspiratory Force Meter (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Weill Medical College of Cornell University
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block		 1; 1; 1; 2; 2; 3 —
PRIMARY
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block		 1; 1; 1; 2; 3; 3 —
SECONDARY
Change in Negative Inspiratory Force (NIF) at 30 Minutes		 -7.5; 0 0.01 sig
SECONDARY
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block		 1; 11; 7; 2; 20; 15 —
SECONDARY
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block		 2; 14; 8; 20; 20; 14 —
SECONDARY
Change in Room Air Oxygen Saturation at 30 Minutes.		 -1; 0 0.01 sig
SECONDARY
Subjective Dyspnea 30 Minutes After Block		 0; 0 0.08

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03138577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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