Headache after dural puncture - influence of cerebrospinal liquid pressure
| ISRCTN | ISRCTN19393727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19393727 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/04/2009
- Registration date
- 27/07/2009
- Last edited
- 27/07/2009
- 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 Schmittner
Scientific
Scientific
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Study information
| Study design | Single centre non-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Correlation of cerebrospinal fluid opening pressure and the incidence of post-dural puncture headache after spinal saddle-block |
| Study objectives | The incidence of post-dural puncture headache seems to be associated with cerebrospinal fluid pressure. |
| Ethics approval(s) | Local medical ethics committee (med. Ethikkommission II; Medizinische Fakultät Mannheim der Ruprechts-Karls-Universität Heidelberg) approved on the 15th December 2008 |
| Health condition(s) or problem(s) studied | Post-dural puncture headache |
| Intervention | Using a 27 gauche Quincke needle for spinal anaesthesia in saddle block technique, measuring the cerebrospinal fluid pressure by using a spinal fluid manometer. All patients were treated according a clincal standard: after dural puncture the dural opening pressure was measured and 1.0 ml cerebrospinal fluid (CSF) preserved. Ambulatory patients receive 1.0 ml scandicaine 4% hyperbaric; in house patients receive 1.0 ml bucaine 0.5% hyperbaric; all patients received a telephone-call 1 week after surgical intervention to obtain information about complications concerning the spinal anaesthesia. |
| Intervention type | Other |
| Primary outcome measure | Post-dural puncture headache and other complications within 7 days. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/04/2009 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Male/female patients with minor perianal surgery 2. Aged 18 - 80 years 3. American Society of Anaesthesioloists (ASA) grade 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 | 15/04/2009 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
68167
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
Industry
B. Braun Melsungen AG (Germany) - provided spinal needles and equipment
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 |
