Contact information
Type
Scientific
Primary contact
Dr Marc Schmittner
ORCID ID
Contact details
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
marc.schmittner@umm.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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.
Acronym
Study hypothesis
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
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
Study design
Randomised prospective controlled single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Diclofenac
Primary outcome measures
1. Analgesic consumption
2. Duration of anaesthesia, recovery room stay and hospitalisation
Secondary outcome measures
1. Practicability
2. Patients satisfaction
Overall trial start date
27/07/2011
Overall trial end date
01/10/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
120
Participant exclusion criteria
1. Contraindications for interscalene plexus block and/or general anaesthesia
2. Allergy to diclofenac
Recruitment start date
27/07/2011
Recruitment end date
01/10/2012
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Centre Mannheim
Mannheim
68167
Germany
Sponsor information
Organisation
University Medical Centre Mannheim [Universitätsmedizin Mannheim] (Germany)
Sponsor details
Department of Anaesthesiology and Intensive Care Medicine
[Klinik für Anästhesiology und Operative Intensivmedizin]
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@umm.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University Medical Centre Mannheim [Universitätsmedizin Mannheim] (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary