Dosing of hyperbaric prilocaine 2% for perianal surgery in an ambulatory setting
| ISRCTN | ISRCTN95628829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95628829 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany) |
| Funder | University Medical Centre Mannheim (Universitätsmedizin Mannheim) (Germany) - Department of Anaesthesiology and Intensive Care Medicine (Klinik für Anästhesiologie und Operative Intensivmedizin) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Prilocaine 2% |
| Primary outcome measure(s) |
Expansion of anaesthesia tested with a toothpick and an ice-filled plastic tube. The expansion of anaesthesia is tested at two points of time: |
| Key secondary outcome measure(s) |
1. Practicability |
| Completion date | 07/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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 |
| Key exclusion criteria | 1. Contraindications for spinal anaesthesia 2. Allergy to diclofenac |
| Date of first enrolment | 07/12/2010 |
| Date of final enrolment | 07/07/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätmedizin Mannheim
Mannheim
68167
Germany
68167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
