Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Shoulder Disease
• Interventions: Procedure: Peripheral nerve blocks

• Registration Number: NCT03877835
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-03-14
• Study Start: 2019-03-18
• Study First Posted: 2019-03-18
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Peripheral nerve blocks	SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml

Primary Outcome Measures

Name	Time	Method
The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes	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.
NRS	Postoperatively at 1 hour	Pain on a 0-10 scale where 0=no pain and 10=unbearable pain

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Troms, Norway