Comparison of anaesthesia methods: single-shot ultrasound guided interscalene block, general anaesthesia and the combination of both, for minor shoulder surgery

ISRCTN	ISRCTN84074316
DOI	https://doi.org/10.1186/ISRCTN84074316
Secondary identifying numbers	N/A

Submission date: 07/10/2011
Registration date: 15/03/2012
Last edited: 15/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc Schmittner
Scientific

University Medical Centre Mannheim
[Universitätmedizin Mannheim]
Department of Anaesthesiology and Intensive Care Medicine
[Klinik für Anästhesiologie und Operative Intensivmedizin]
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email	marc.schmittner@umm.de

Study information

Study design	Randomised prospective controlled single centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomized prospective clinical study for evaluation of practicability, postoperative analgetic consumption and patients' satisfaction of patients undergoing minor shoulder surgery with ultrasound guided single-shot interscalene plexus block versus total anesthesia versus combination of both methods.
Study objectives	Minor shoulder surgery can be performed with several anaesthesia techniques. Patients and doctors, have curently uncertainties about the anaesthesia which should be performed for minor shoulder surgery. Due to multiple irrational fears, many patients deny local anaesthesia and prefer a general anaesthesia. Anaesthesiologists are concerned about sufficient pain management when performing only a ultrasound guided interscalene singe-shot plexus block. In this study we evaluate the practicability, complications, patients' satisfaction and the analgetic consumption for total anaesthesia versus ultrasound guided interscalene block versus the combination of both methods.
Ethics approval(s)	Medical Ethics Committee II, Faculty of Medicine, Ruprecht Karl University of Heidelberg [Medizinische Ethikkommission II: MEdizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg], 27 January 2011 ref: AZ.2010-355N-MA
Health condition(s) or problem(s) studied	Minor shoulder surgery
Intervention	Participants are randomised (1:1:1) to either ultrasound guided single-shot interscalene plexus block or total anesthesia or combination of both techniques. When performing an interscalene plexus block the expansion of anaesthesia is tested by discrimination of warm and cold. Duration, complications and quality of the performed interscalene block are documentated as well as need for additional analgetic treatment and pharmaceuticals used for total anaesthesia. Patients are treated with a standard analgetic scheme and are asked to fill in a questionnaire 24 hours after surgery.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Diclofenac
Primary outcome measure	1. Analgesic consumption 2. Duration of anaesthesia, recovery room stay and hospitalisation
Secondary outcome measures	1. Practicability 2. Patients satisfaction
Overall study start date	27/07/2011
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Male
Target number of participants	120
Key inclusion criteria	1. Patients (male/female) undergoing minor shoulder arthroscopy 2. Aged 18-80 years 3. American Society of Anesthesiologists (ASA) physical status I-III 4. No contraindications for interscalene plexus block and/or general anaesthesia
Key exclusion criteria	1. Contraindications for interscalene plexus block and/or general anaesthesia 2. Allergy to diclofenac
Date of first enrolment	27/07/2011
Date of final enrolment	01/10/2012

Locations

Countries of recruitment

Germany

Study participating centre

University Medical Centre Mannheim

Mannheim
68167
Germany

Sponsor information

University Medical Centre Mannheim [Universitätsmedizin Mannheim] (Germany)
Hospital/treatment centre

Department of Anaesthesiology and Intensive Care Medicine
[Klinik für Anästhesiology und Operative Intensivmedizin]
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email	marc.schmittner@umm.de
Website	http://www.umm.de/
"ROR"	https://ror.org/05sxbyd35

Funders

Funder type

University/education

University Medical Centre Mannheim [Universitätsmedizin Mannheim] (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan