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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

Tracking Information
First Submitted Date  ICMJE February 8, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • NRS [ Time Frame: Postoperatively at 1 hour ]
    Pain on a 0-10 scale where 0=no pain and 10=unbearable pain
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
Official Title  ICMJE Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Shoulder Disease
Intervention  ICMJE Procedure: Peripheral nerve blocks
LSIB + SSNB
Study Arms  ICMJE Ropivacaine
SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml
Intervention: Procedure: Peripheral nerve blocks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877835
Other Study ID Numbers  ICMJE REK 2018/1934-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Nordlandssykehuset Bodo
Investigators  ICMJE Not Provided
PRS Account University Hospital of North Norway
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP