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OpenTrials
Completed

NCT Number: NCT03657173

Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy

Ultrasound guided interscalene nerve blockade with local anesthesia is a standard regional anesthetic technique for providing postoperative analgesia during shoulder arthroscopy and wide variety of shoulder procedures. There is a paucity of data regarding the effects of shoulder arthroscopy on ultrasound image quality, including the effects of muscle mobilization and the use of large volume irrigation and subsequent tissue absorption, though increased neck circumference and airway edema are known complications of arthroscopic shoulder procedures.

The objective of the study is to determine if there is a difference in ultrasound image quality of the interscalene block anatomy, by Likert scale, pre- versus post-operatively in a cohort of patients undergoing shoulder arthroscopy who routinely receive blockade of the brachial plexus for postoperative analgesia. Further, if there are differences in imaging quality, correlations with surgical and patient factors will be studied.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is undergoing shoulder procedures involving arthroscopy
  • Subject has consented to interscalene blockade for postoperative analgesia

Exclusion criteria

  • Patient refusal
  • Contraindications to interscalene blockade, including significant pulmonary insufficiency, hemi-diaphragmatic paralysis, brachial plexus or degenerative neuropathy
  • Allergy to proposed local anesthetic medication\\
  • Severe cervical spine disease.
  • BMI >40 kg/m2
  • Neck Circumference > 50cm
  • Failed preoperative interscalene blockade
  • Patients known to be currently pregnant or actively breastfeeding
  • Patients where English is a language barrier

Treatment and study plan

Primary outcomes

  1. Change in Likert Scale

    Time frame: 2-3 months

    Ultrasound media will be scored using a Likert scale (from 1-5 based on quality of imaging) individually for pre-operative and post-operative scanning for each enrolled patient

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy: a Prospective Cohort Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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