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
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Disease||Procedure: Peripheral nerve blocks||Not Applicable|
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 :||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|
|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|
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
- 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.
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
|University Hospital of North Norway||Recruiting|
|Tromsø, Troms, Norway, 9038|
|Contact: Eva-Hanne Hansen +4795259201 firstname.lastname@example.org|
|Sub-Investigator: Dario F Musso, MD|
|Principal Investigator: Lars M Ytrebø, Professor|
|Sub-Investigator: Oivind Klaastad, Professor|