Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

NCT ID: NCT03877835

Last Updated: 2021-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Shoulder Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Outcome measures will be performed by an independent assessor

Study Groups

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Ropivacaine

SSNB will be performed with 4 ml ropivacaine 5 mg/ml LSIB will be performed With 15 ml ropivacaine 7.5 mg/ml

Group Type OTHER

Peripheral nerve blocks

Intervention Type PROCEDURE

LSIB + SSNB

Interventions

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Peripheral nerve blocks

LSIB + SSNB

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordlandssykehuset Bodo

UNKNOWN

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of North Norway

Tromsø, Troms, Norway

Site Status

Countries

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Norway

Other Identifiers

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REK 2018/1934-3

Identifier Type: -

Identifier Source: org_study_id

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