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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657173
• Other study ID #: 18-004131
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Likert Scale	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	2-3 months