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Treatment group for Upper Extremity Injuries

N/A
Waitlist Available
Led By Ban Tsui, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.)
Awards & highlights

Study Summary

Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

Eligible Conditions
  • Upper Extremity Injuries
  • Phrenic Nerve Palsy
  • Local Anesthesia
  • Phrenic Nerve Paralysis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in forced expiratory volume in 1 second (FEV1)
Change in forced vital capacity (FVC)
Change in peak expiratory flow (PEF)
Secondary outcome measures
Brachial plexus sensory and motor exam
Diaphragmatic excursion
Pain scores

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment groupActive Control1 Intervention
After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This group will then have 30ml of normal saline injected into their nerve catheter. Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
Group II: Placebo groupPlacebo Group1 Intervention
After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This control group will have no normal saline injected into their nerve catheter (no intervention). Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,149 Total Patients Enrolled
1 Trials studying Upper Extremity Injuries
30 Patients Enrolled for Upper Extremity Injuries
Ban Tsui, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Upper Extremity Injuries
30 Patients Enrolled for Upper Extremity Injuries

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
Chi-Ho Ban Tsui 2018. "Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03677778.
~7 spots leftby Apr 2025
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