NCT03657173

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

August 27, 2018

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

Locations