27G-Quincke® vs 27G-Pencil-Point® spinal needles for spinal saddle block
| ISRCTN | ISRCTN12262174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12262174 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/02/2009
- Registration date
- 26/05/2009
- Last edited
- 26/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Universitätsmedizin Mannheim
Klinik für Anästhesiologie und Operative Intensivmedizin
Theodor-Kutzer-Ufer 1-3
Mannheim
69167
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 |
| Scientific title | Comparison of 27G-Quincke® vs 27G-Pencil-Point® spinal needles and 10 vs 30 minutes fixation time for spinal saddle block regarding the incidence of post-dural puncture headache |
| Study objectives | The incidence of post-dural puncture headache in spinal saddle block seems to be associated with the time given for fixation of the local anaesthetic. Under the assumption of an elevated cerebro-spinal-fluid pressure in the lumbar spine in the sitting position we hypothesised that (a) using a 27G-Pencil-Point® spinal needle instead of a 27G-Quincke-type® spinal needle AND (b) leaving the patient in the upright position for fixation of the local anaesthetic for 10 instead of 30 minutes would reduce the incidence of post-dural-puncture headache. |
| 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 27/09/2008. |
| Health condition(s) or problem(s) studied | Post-dural puncture headache |
| Intervention | Patients are randomised 1:1:1:1 to: A: 27-gauge Quincke® needle, being left in the upright postion for 10 minutes B: 27-gauge Quincke® needle, being left in the upright postion for 30 minutes C: 27-gauge Pencil-Point® needle, being left in the upright postion for 10 minutes D: 27-gauge Pencil-Point® needle, being left in the upright postion for 30 minutes Patients receive a questionnaire and phone call one week later to obtain information about satisfaction and occurring complications. The time for the performance of the spinal anaesthesia and problems with the handling of the spinal needle are recorded by the anaesthesiologist. |
| Intervention type | Other |
| Primary outcome measure | Incidence of post-dural puncture headache and other complications, measured one week after anaesthesia. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2008 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Patients (male/female) with 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 local anaesthetics |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsmedizin Mannheim
Mannheim
69167
Germany
69167
Germany
Sponsor information
B. Braun Melsungen AG (Germany)
Industry
Industry
Carl-Braun-Strasse 1
Melsungen
34212
Germany
| Website | http://www.bbraun.com |
|---|---|
"ROR" |
https://ror.org/04nxj7050 |
Funders
Funder type
University/education
University of Heidelberg (Germany) - main funder
No information available
B. Braun Melsungen AG (Germany) - provided the spinal needles
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 |
