Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Umeå University | OTHER |
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sprotte 25G needle, stylet reinserted | Experimental |
| |
| Sprotte 25G needle, stylet not reinserted | Experimental |
| |
| Sprotte 22G needle, stylet reinserted | Experimental |
| |
| Sprotte 22G needle, stylet not reinserted | Experimental |
| |
| Spinocan 25G needle, stylet reinserted | Experimental |
| |
| Spinocan 25G needle, stylet not reinserted | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sprotte 25G needle, stylet reinserted | Device | Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Odds ratio for post-lumbar puncture headache (any) | Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3). | Up to 14 days after LP |
| Measure | Description | Time Frame |
|---|---|---|
| Odds ratio for post-lumbar puncture headache (severe) | Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3). | Up to 14 days after LP |
| Headache duration (days) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration (minutes) | Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant). | During the lumbar puncture |
| Proportion undergoing needle switch |
Inclusion Criteria:
Exclusion Criteria:
-Subjects unable to participate in the study follow-up
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11061243 | Background | Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available. | |
| 19009898 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2014 |
Not provided
Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Not provided
Not provided
The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
| Sprotte 25G needle, stylet not reinserted | Device | Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal |
|
| Sprotte 22G needle, stylet reinserted | Device | Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal |
|
| Sprotte 22G needle, stylet not reinserted | Device | Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal |
|
| Spinocan 25G needle, stylet reinserted | Device | Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal |
|
| Spinocan 25G needle, stylet not reinserted | Device | Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal |
|
| Until cessation, up to 14 days after LP |
| Proportion using analgesia | During post-lumbar puncture headache, up to 14 days after LP |
| Proportion on sick leave | During post-lumbar puncture headache, up to 14 days after LP |
| Proportion with back pain | Up to 14 days after LP |
| Proportion with radiating leg pain | Up to 14 days after LP |
| Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model | Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables. | Up to 14 days after LP |
Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ. |
| During the lumbar puncture |
| Opening pressure (cm H2O) | Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point. This is only performed in the recumbent position. | During the lumbar puncture |
| Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish. |
| 16116106 | Background | Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b. |
| 9102578 | Background | Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available. |
| 21549395 | Background | Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5. |
| 11756618 | Background | Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310. |
| May 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided