Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

Shoulder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877835
• Other study ID #: REK 2018/1934-3
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Disease

Intervention

Procedure:
• Peripheral nerve blocks
LSIB + SSNB

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Nordlandssykehuset Bodo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS	Pain on a 0-10 scale where 0=no pain and 10=unbearable pain	Postoperatively at 1 hour
Primary	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