Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJanuary 30, 2019
January 1, 2019
6 months
August 27, 2018
January 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Adult patients (\>18 years of age) undergoing shoulder procedures involving arthroscopy who have consented to interscalene blockade for postoperative analgesia.
You may qualify if:
- Subject is undergoing shoulder procedures involving arthroscopy
- Subject has consented to interscalene blockade for postoperative analgesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55902, United States
Related Publications (1)
Panchamia JK, Jagannathan R, Pulos BP, Amundson AW, Sanchez-Sotelo J, Martin DP, Smith HM. The effects of shoulder arthroscopy on ultrasound image quality of the interscalene brachial plexus: a pre-procedure vs post-procedure comparative study. BMC Anesthesiol. 2021 Jul 9;21(1):187. doi: 10.1186/s12871-021-01409-3.
PMID: 34243720DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 27, 2018
First Posted
September 4, 2018
Study Start
June 18, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
January 30, 2019
Record last verified: 2019-01