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NCT03138577

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

Completed Phase 4 Results posted Last updated 13 May 2020
What this trial tests

Phase 4 trial testing Ultrasound Imaging in Surgery of Right Upper Extremity in 24 participants. Completed in 30 July 2019.

Timeline
12 February 2018
Primary endpoint
30 July 2019
30 July 2019

Quick facts

Lead sponsorWeill Medical College of Cornell University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment24
Start date12 February 2018
Primary completion30 July 2019
Estimated completion30 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 105, any sex, with Surgery of Right Upper Extremity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block Primary · 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.

GroupValue95% CI
Dose Cohort 7 (5 mL)1
Dose Cohort 6 (10 mL)1
Dose Cohort 5 (15 mL)1
Dose Cohort 4 (20 mL)2
Dose Cohort 3 (25 mL)2
Dose Cohort 2 (30 mL)3
Dose Cohort 1 (35 mL)3
Dose Cohort 7 (5 mL)2
Dose Cohort 6 (10 mL)2
Dose Cohort 5 (15 mL)2
Dose Cohort 4 (20 mL)1
Dose Cohort 3 (25 mL)1
Dose Cohort 2 (30 mL)0
Dose Cohort 1 (35 mL)0
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block Primary · 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.

GroupValue95% CI
Dose Cohort 7 (5 mL)1
Dose Cohort 6 (10 mL)1
Dose Cohort 5 (15 mL)1
Dose Cohort 4 (20 mL)2
Dose Cohort 3 (25 mL)3
Dose Cohort 2 (30 mL)3
Dose Cohort 1 (35 mL)3
Dose Cohort 7 (5 mL)2
Dose Cohort 6 (10 mL)2
Dose Cohort 5 (15 mL)2
Dose Cohort 4 (20 mL)1
Dose Cohort 3 (25 mL)0
Dose Cohort 2 (30 mL)0
Dose Cohort 1 (35 mL)0
Change in Negative Inspiratory Force (NIF) at 30 Minutes Secondary · 30 minutes

The change of the absolute value of NIF from the baseline measurement to that at 30 minutes after the block

GroupValue95% CI
Subjects With HDP-7.5-22.0 – 0
Subjects Without HDP0-10 – 0
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block Secondary · 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.

Subject 1/3
GroupValue95% CI
Dose Cohort 7 (5 mL)1
Dose Cohort 6 (10 mL)11
Dose Cohort 5 (15 mL)7
Dose Cohort 4 (20 mL)2
Dose Cohort 3 (25 mL)20
Dose Cohort 2 (30 mL)15
Dose Cohort 1 (35 mL)11
Subject 2/3
GroupValue95% CI
Dose Cohort 7 (5 mL)12
Dose Cohort 6 (10 mL)12
Dose Cohort 5 (15 mL)0
Dose Cohort 4 (20 mL)1
Dose Cohort 3 (25 mL)19
Dose Cohort 2 (30 mL)15
Dose Cohort 1 (35 mL)15
Subject 3/3
GroupValue95% CI
Dose Cohort 7 (5 mL)10
Dose Cohort 6 (10 mL)0
Dose Cohort 5 (15 mL)18
Dose Cohort 4 (20 mL)0
Dose Cohort 3 (25 mL)5
Dose Cohort 2 (30 mL)16
Dose Cohort 1 (35 mL)19
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block Secondary · 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.

Subject 1 of 3
GroupValue95% CI
Dose Cohort 7 (5 mL)2
Dose Cohort 6 (10 mL)14
Dose Cohort 5 (15 mL)8
Dose Cohort 4 (20 mL)20
Dose Cohort 3 (25 mL)20
Dose Cohort 2 (30 mL)14
Dose Cohort 1 (35 mL)15
Subject 2 of 3
GroupValue95% CI
Dose Cohort 7 (5 mL)18
Dose Cohort 6 (10 mL)14
Dose Cohort 5 (15 mL)2
Dose Cohort 4 (20 mL)10
Dose Cohort 3 (25 mL)20
Dose Cohort 2 (30 mL)16
Dose Cohort 1 (35 mL)18
Subject 3 of 3
GroupValue95% CI
Dose Cohort 7 (5 mL)10
Dose Cohort 6 (10 mL)12
Dose Cohort 5 (15 mL)18
Dose Cohort 4 (20 mL)16
Dose Cohort 3 (25 mL)16
Dose Cohort 2 (30 mL)16
Dose Cohort 1 (35 mL)19
Change in Room Air Oxygen Saturation at 30 Minutes. Secondary · 30 minutes

The change in room air oxygen saturation from baseline to 30 minutes after the block was calculated.

GroupValue95% CI
Subjects With HDP-1-2 – 0
Subjects Without HDP00 – 0
Subjective Dyspnea 30 Minutes After Block Secondary · 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).

GroupValue95% CI
Subjects With HDP00 – 2
Subjects Without HDP00 – 0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Dose-response relationship between local anesthetic volume and hemidiaphragmatic paresis following ultrasound-guided supraclavicular brachial plexus blockade.
    Tedore TR, Lin HX, Pryor KO, Tangel VE, et al · · 2020 · cited 20× · PMID 33004656 · DOI 10.1136/rapm-2020-101728

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