Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Disease
• Intervention / Treatment: Procedure: Peripheral nerve blocks

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9038
      • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	Pain on a 0-10 scale where 0=no pain and 10=unbearable pain	Postoperatively at 1 hour
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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Nordlandssykehuset Bodo

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: REK 2018/1934-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No