Background We designed a device to close accidental dural puncture via the offending puncturing epidural needle directly after diagnosis of the puncture and before removing the needle. The aim of this study was to quantify this device’s ability to seal cerebrospinal fluid leakage.
Methods Forty-six anesthetized adult sheep were studied in a single-blind randomized controlled fashion in two equal groups.
An intentional dural puncture was performed with an 18-gage Tuohy needle on all the sheep between L6 and S1 levels. Contrast medium was injected through the needle. Twenty-three animals receive treatment with the sealing device. Two minutes after device placement, or dural puncture in the control group, a CT scan was performed on the animals to estimate contrast material leakage. A region of interest (ROI) was defined as the region that enclosed the subarachnoid space, epidural space, and neuroforaminal canal (the vertebral body above and half of its equivalent height in sacrum below the puncture site). In this region, the total contrast volume and the volumes in the epidural space (EPIDURAL) were measured. The primary outcome measure was the EPIDURAL/ROI ratio to ascertain the proportion of intrathecally injected fluid that passed into the epidural space in both groups. The secondary outcomes were the total amount of contrast in the ROI and the EPIDURAL.
Results The device was deployed successfully in all but two instances, where it suffered from manufacturing defects.
Leakage was less in the study group (1.0 vs 1.4 mL, p=0.008). The median EPIDURAL/ROI ratio was likewise less in the study group (29 vs 46; p=0.013; 95% CI (−27 to –3.5)).
Conclusion This novel dural puncture-sealing device, also envisaged to be used in other comparable iatrogenic leakage scenarios to be identified in the future, was able to reduce the volume of cerebrospinal fluid that leaked into the epidural space after dural puncture. The device is possibly a valuable way of preventing fluid leakage immediately after the recognition of membrane puncture.
- post-dural puncture headache
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Contributors All authors contributed to the conception, data gathering and analysis, and writing of this manuscript.
Funding Support was provided by the Fondo de Investigación Sanitaria-Instituto Carlos III (project number DTS17/00053) and by the European Society of Regional Anaesthesia (research grant number 2018).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This project was approved by the
General Directorate of Livestock of the Generalitat Valenciana (Spain; code 2018/VSC/PEA/0188 type 2) and Ethics Committee for Animal Experimentation at the CEU-Cardenal Herrera University (Valencia, Spain).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.