Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of 0.5ml vs. 1.0ml vs. 1.5ml hyperbaric prilocaine 2% for spinal saddle block in patients undergoing perianal surgery in an ambulatory setting
Acronym
Study hypothesis
In 2010 hyperbaric prilocaine 2% was introduced on the German market. There is no evidence based data about dosing of hyperbaric prilocaine 2% for perianal surgery. In this trial we compare the expansion of the saddle block according to three dosages of hyperbaric prilocaine 2%.
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), approved on 21st September 2010 (ref: AZ.: 2010-303N-MA)
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Colorectal diseases
Intervention
Participants are randomised (1:1:1) to a dose of either 0.5ml or 1.0ml or 1.5ml of hyperbaric prilocaine 2%. The expansion of anaesthesia is tested with a toothpick and an ice-filled plastic tube.
Intervention type
Drug
Phase
Not Applicable
Drug names
Prilocaine 2%
Primary outcome measure
Expansion of anaesthesia tested with a toothpick and an ice-filled plastic tube. The expansion of anaesthesia is tested at two points of time:
1. After positioning of the patient for operation
2. Directly after the procedure has ended
Secondary outcome measures
1. Practicability
2. Postoperative analgetic consumption
3. Duration of stay in hospital
Overall trial start date
07/12/2010
Overall trial end date
07/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients (male/female) undergoing minor perianal surgery
2. Age: 18-80 years
3. American Society of Anesthesiologists (ASA) physical status I-III
4. No contraindications for spinal anaesthesia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Contraindications for spinal anaesthesia
2. Allergy to diclofenac
Recruitment start date
07/12/2010
Recruitment end date
07/07/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätmedizin Mannheim
Mannheim
68167
Germany
Funders
Funder type
University/education
Funder name
University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany) - Department of Anaesthesiology and Intensive Care Medicine (Klinik für Anästhesiologie und Operative Intensivmedizin)
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
Basic results (scientific)
Publication list