Headache after dural puncture - influence of cerebrospinal liquid pressure
| ISRCTN | ISRCTN19393727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19393727 |
| Protocol serial number | N/A |
| Sponsor | B. Braun Melsungen AG (Germany) |
| Funder | B. Braun Melsungen AG (Germany) - provided spinal needles and equipment |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised controlled trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Post-dural puncture headache and other complications within 7 days. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
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 |
