NCT03138577

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 24, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

April 24, 2017

Results QC Date

April 29, 2020

Last Update Submit

April 29, 2020

Conditions

Surgery of Right Upper Extremity

Outcome Measures

Primary Outcomes (2)

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

    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.

    15 minutes

  • Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block

    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.

    30 minutes

Secondary Outcomes (5)

  • Change in Negative Inspiratory Force (NIF) at 30 Minutes

    30 minutes

  • Dose Response Curve for Motor and Sensory Block 15 Minutes After Block

    15 minutes

  • Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block

    30 minutes

  • Change in Room Air Oxygen Saturation at 30 Minutes.

    30 minutes

  • Subjective Dyspnea 30 Minutes After Block

    30 minutes

Study Arms (7)

Dose Cohort 7

OTHER

5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 6

OTHER

10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 5

OTHER

15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 4

OTHER

20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 3

OTHER

Supraclavicular Block: 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 2

OTHER

30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Dose Cohort 1

OTHER

35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine Ultrasound Imaging Bedside Negative Inspiratory Force Meter

Diagnostic Test: Ultrasound ImagingDrug: Supraclavicular BlockOther: Bedside Negative Inspiratory Force Meter

Interventions

Ultrasound ImagingDIAGNOSTIC_TEST

M-mode tracings of right diaphragm motion will be made and recorded by a skilled anesthesiologist. Patients will be examined in the supine position and scanned from a low intercostal or subcostal approach using the liver as an acoustic window. Patients will be asked to perform a "voluntary sniff" (VS) test, for which they will be asked to forcefully inhale through the nose in a sniffing position. The above measurement will be performed immediately preceding the brachial plexus blockade, and then at 15 minute and 30 minutes after block.

Dose Cohort 1Dose Cohort 2Dose Cohort 3Dose Cohort 4Dose Cohort 5Dose Cohort 6Dose Cohort 7
Supraclavicular BlockDRUG

The patient will be positioned supine with the head turned to the contralateral side. The ultrasound will be placed in the supraclavicular fossa, and the skin and subcutaneous tissues will be infiltrated lateral to the probe with 2% lidocaine. The anesthesiologist can redirect the needle and perform additional injections for complete coverage of the brachial plexus. The local anesthetic will be a 2:1 mix of 1.5% mepivacaine and 0.5% bupivacaine.

Dose Cohort 1Dose Cohort 2Dose Cohort 3Dose Cohort 4Dose Cohort 5Dose Cohort 6Dose Cohort 7
Bedside Negative Inspiratory Force MeterOTHER

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.

Dose Cohort 1Dose Cohort 2Dose Cohort 3Dose Cohort 4Dose Cohort 5Dose Cohort 6Dose Cohort 7

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (11)

  • Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.

    PMID: 19916254BACKGROUND

  • Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.

    PMID: 25650633BACKGROUND

  • Kant A, Gupta PK, Zohar S, Chevret S, Hopkins PM. Application of the continual reassessment method to dose-finding studies in regional anesthesia: an estimate of the ED95 dose for 0.5% bupivacaine for ultrasound-guided supraclavicular block. Anesthesiology. 2013 Jul;119(1):29-35. doi: 10.1097/ALN.0b013e31829764cf.

    PMID: 23648519BACKGROUND

  • Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

    PMID: 19017880BACKGROUND

  • Mier-Jedrzejowicz A, Brophy C, Moxham J, Green M. Assessment of diaphragm weakness. Am Rev Respir Dis. 1988 Apr;137(4):877-83. doi: 10.1164/ajrccm/137.4.877.

    PMID: 3354995BACKGROUND

  • Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.

    PMID: 17196502BACKGROUND

  • Tedore TR, YaDeau JT, Maalouf DB, Weiland AJ, Tong-Ngork S, Wukovits B, Paroli L, Urban MK, Zayas VM, Wu A, Gordon MA. Comparison of the transarterial axillary block and the ultrasound-guided infraclavicular block for upper extremity surgery: a prospective randomized trial. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):361-5. doi: 10.1097/AAP.0b013e3181ac9e2d.

    PMID: 19574870BACKGROUND

  • O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics. 1990 Mar;46(1):33-48.

    PMID: 2350571BACKGROUND

  • Garrett-Mayer E. The continual reassessment method for dose-finding studies: a tutorial. Clin Trials. 2006;3(1):57-71. doi: 10.1191/1740774506cn134oa.

    PMID: 16539090BACKGROUND

  • Neal JM. Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):195-204. doi: 10.1097/AAP.0000000000000295.

    PMID: 26695877BACKGROUND

  • Tedore TR, Lin HX, Pryor KO, Tangel VE, Pak DJ, Akerman M, Wellman DS, Oden-Brunson H. Dose-response relationship between local anesthetic volume and hemidiaphragmatic paresis following ultrasound-guided supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2020 Dec;45(12):979-984. doi: 10.1136/rapm-2020-101728. Epub 2020 Oct 1.

    PMID: 33004656DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Limitations and Caveats

1. The subjects enrolled in this trial were predominantly female. 2. The subject population studied was free from baseline respiratory disease.

Results Point of Contact

Title
Dr. Tiffany Tedore
Organization
Weill Cornell Medical College
tft9001@med.cornell.edu
212-746-2725

Study Officials

  • Tiffany Tedore, MD

    WCMC, NYP

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The physician reviewing the ultrasound images and determining the presence/absence of diaphragm paralysis is masked to treatment assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 3, 2017

Study Start

February 12, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

May 13, 2020

Results First Posted

May 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)