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Clinical Trials/NCT03677778
NCT03677778
Completed
Not Applicable

Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

Stanford University1 site in 1 country43 target enrollmentOctober 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Stanford University
Enrollment
43
Locations
1
Primary Endpoint
Change in forced vital capacity (FVC)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.

The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.

Registry
clinicaltrials.gov
Start Date
October 22, 2018
End Date
July 7, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chi-Ho Ban Tsui

Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in forced vital capacity (FVC)

Time Frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

Change in peak expiratory flow (PEF)

Time Frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

Change in forced expiratory volume in 1 second (FEV1)

Time Frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

Secondary Outcomes

  • Pain scores(Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments))
  • Brachial plexus sensory and motor exam(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments).)
  • Diaphragmatic excursion(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.))

Study Sites (1)

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