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Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT03877835
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Nordlandssykehuset Bodo
Information provided by (Responsible Party):
University Hospital of North Norway

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.

Condition or disease Intervention/treatment Phase
Shoulder Disease Procedure: Peripheral nerve blocks Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single intervention
Masking: None (Open Label)
Masking Description: Outcome measures will be performed by an independent assessor
Primary Purpose: Treatment
Official Title: Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Ropivacaine
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
LSIB + SSNB




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years old,
  • BMI 20-35 kg.m-2
  • ASA physical status 1-3

Exclusion Criteria:

  • unable to concent,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877835


Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Eva-Hanne Hansen    +4795259201    eva-hanne.hansen@unn.no   
Sub-Investigator: Dario F Musso, MD         
Principal Investigator: Lars M Ytrebø, Professor         
Sub-Investigator: Oivind Klaastad, Professor         
Sponsors and Collaborators
University Hospital of North Norway
Nordlandssykehuset Bodo

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03877835     History of Changes
Other Study ID Numbers: REK 2018/1934-3
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents