Dosing of hyperbaric prilocaine 2% for perianal surgery in an ambulatory setting
| ISRCTN | ISRCTN95628829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95628829 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2011
- Registration date
- 06/06/2011
- Last edited
- 06/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Marc D Schmittner
Scientific
Scientific
Universitätmedizin Mannheim
Klinik für Anästhesiologie und Operative Intensivmedizin
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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 |
| 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(s) | 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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 07/12/2010 |
| Overall study end date | 07/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 120 |
| 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 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
Study participating centre
Universitätmedizin Mannheim
Mannheim
68167
Germany
68167
Germany
Sponsor information
University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany)
University/education
University/education
Klinik für Anästhesiology und Operative Intensivmedizin
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
"ROR" |
https://ror.org/05sxbyd35 |
|---|
Funders
Funder type
University/education
University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany) - Department of Anaesthesiology and Intensive Care Medicine (Klinik für Anästhesiologie und Operative Intensivmedizin)
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 |
