Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-02-28

Brief Summary

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Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.

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Detailed Description

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Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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effectiveness of interscalene brachial plexus single-shot

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

Group Type ACTIVE_COMPARATOR

single bolus injection

Intervention Type PROCEDURE

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

continuous interscalene brachial plexus block

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used.

Group Type EXPERIMENTAL

the ISBC group, SonoPlex needle and E-catheter

Intervention Type PROCEDURE

in the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula.

Interventions

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the ISBC group, SonoPlex needle and E-catheter

in the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula.

Intervention Type PROCEDURE

single bolus injection

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesia (ASA) physical status of 1 to 2,
* Body Mass Index (BMI) of less than 30 kg/m²,
* paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.

Exclusion Criteria

* skin infection on the puncture site,
* coagulopathy
* brachial plexus neuropathy
* alcohol or drug abuse
* diabetes
* severe lung disease
* history of allergy to one or more study drugs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No