Condition category
Musculoskeletal Diseases
Date applied
07/10/2011
Date assigned
15/03/2012
Last edited
15/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umm.de/

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

Publication citations

Additional files

Editorial Notes