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Completed

NCT Number: NCT03877835

Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

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.

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Key information

Conditions

Shoulder Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

About this study

The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty.

The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-78 years old,
  • BMI 20-35 kg.m-2
  • ASA physical status 1-3

Exclusion criteria

  • 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.

Treatment and study plan

peripheral nerve blocks

Procedure

LSIB + SSNB

Primary outcomes

  1. NRS

    Time frame: Postoperatively at 1 hour

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

  2. The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes

    Time frame: 30 minutes after the blocks

    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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Nordlandssykehuset Bodo

Registry information

Official study title

Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2019
Registry last updated
Jan 7, 2021

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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