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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00009908
Date of registration:	26/01/2016
Prospective Registration:	No
Primary sponsor:	Berufsgenossenschaftliche Unfallklinik Tübingen, Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie
Public title:	ultrasound guided scalene brachial Plexus block in patients recieving elecitve shoulder surgery in regional anesthesia with sedation
Scientific title:	ultrasound guided scalene brachial Plexus block in patients recieving elecitve shoulder surgery in regional anesthesia with sedation
Date of first enrolment:	21/09/2011
Target sample size:	84
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00009908
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: prevention
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Lars Bergmann
Address:	In der Schornau 23-25 44892 Bochum Germany
Telephone:	023429983001
Email:	lars.bergmann@kk-bochum.de
Affiliation:	Universitätsklinikum Knappschaftskrankenhaus Bochum

Name:	Lars Bergmann
Address:	In der Schornau 23-25 44982 Bochum Germany
Telephone:	02342993001
Email:	lars.bergmann@kk-bochum.de
Affiliation:	Universitätsklinikum Knappschaftskrankenhaus Bochum, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

Key inclusion & exclusion criteria

Inclusion criteria: ASA I-II, patients sheduled for elective arthroscopic or open surgery of the shoulder
Exclusion criteria: Patient's refusal, allergy against the local anesthetic used, preexsisting damage of the brachial Plexus, psychiatric disorders, ispi or contrallateral paresis of the phrencus nerve, infection of the Skin, impaired coagulation, preexisting lung disease (GOLD >2,3,4)

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rotator cuff syndrome

M75.1

Impingement syndrome of shoulder

M75.4

M75.4
M75.1

Intervention(s)

Group 1: Patient scheduled for elecitve shoulder surgery with anterior Approach to the interscalene Plexus brachialis
Group 2: Patient scheduled for elecitve shoulder surgery with posterior Approach to the interscalene Plexus brachialis

Primary Outcome(s)

nervus phrenicus block - measured with spirometric examination before interscalene block and after complete motor block of the upper extremity

Secondary Outcome(s)

Successful motor block, difference in success related to the anterior or posterior Approach, examinated with clinical examination

Secondary ID(s)

Source(s) of Monetary Support

Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 17/03/2011
Contact:

Results

Results available:
Date Posted:
Date Completed:	19/09/2012
URL:	http://drks.de/search/en/trial/DRKS00009908#studyResults

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