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Validation of a bioabsorbable device that seals perforations after Tuohy needle dural puncture in an ovine model
  1. Carles García-Vitoria1,
  2. Mireia García -Roselló2,
  3. Miguel A Reina3,4,5,
  4. Jose De Andres6,7,
  5. Álvaro Jesús Gutiérrez-Bautista2,
  6. Vicente Esteve2,
  7. Andre Boezaart5,8 and
  8. Jose I Redondo9
  1. 1Department of Anesthesiology, Critical Care and Pain Management, Hospital Intermutual de Levante, San Antonio de Benagéber, Valencia, Spain
  2. 2Facultad de Veterinaria, CEU Universidad Cardenal Herrera, Valencia, Comunitat Valenciana, Spain
  3. 3Department of Anesthesiology, CEU-San Pablo University School of Medicine, Madrid, Spain
  4. 4Department of Anesthesiology, Madrid-Montepríncipe University Hospital, Madrid, Spain
  5. 5Division of Acute and Perioperative Pain Medicine, Department of Anesthesiology, University of Florida College of Medicine, Florida, Gainesville, Florida, USA
  6. 6Anesthesia Unit - Surgical Specialties Department, University of Valencia, Valencia, Spain
  7. 7Department of Anesthesiology, Critical Care and Pain Management, General University Hospital, Valencia, Spain
  8. 8Alon P Winnie Research Institute, Still Bay, Western Province, South Africa
  9. 9Departamento de Medicina y Cirugía Animal, CEU Universidad Cardenal Herrera, Moncada, Comunitat Valenciana, Spain
  1. Correspondence to Dr Carles García-Vitoria, Anesthesiology and Pain Management, Hospital Intermutual de Levante, San Antonio de Benageber 46184, Spain; carlesgvitoria{at}gmail.com

Abstract

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
  • injections
  • spinal
  • analgesia

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Footnotes

  • 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.

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