NCT03877835

Brief Summary

The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

February 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 7, 2021

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

February 8, 2019

Last Update Submit

January 4, 2021

Conditions

Shoulder Disease

Outcome Measures

Primary Outcomes (2)

  • NRS

    Pain on a 0-10 scale where 0=no pain and 10=unbearable pain

    Postoperatively at 1 hour

  • The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes

    Hemidiaphragmatic paralysis was defined as the absence of diaphragmatic motion during normal respiration, coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffed.

    30 minutes after the blocks

Study Arms (1)

Ropivacaine

OTHER

SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml

Procedure: Peripheral nerve blocks

Interventions

Peripheral nerve blocksPROCEDURE

LSIB + SSNB

Ropivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old,
  • BMI 20-35 kg.m-2
  • ASA physical status 1-3

You may not qualify if:

  • unable to consent,
  • pregnancy,
  • pre-existing severe respiratory disease,
  • use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol,
  • allergy to local anaesthetics,
  • patients on regular opioids,
  • atrioventricular block,
  • peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Outcome measures will be performed by an independent assessor
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2019

First Posted

March 18, 2019

Study Start

March 18, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 7, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)