Kateter sabitlemesinde güvenli ve etkin bir yöntem için cihaz modeli geliştirilmesi: Deneysel bir çalışma
Öz
Amaç: Günümüzde kullanılan kalıcı kateter sabitleme yöntemleri epidural kateterin yer değiştirmesine veya dışarı çıkmasına neden olabilmektedir. Bu durum, kateter göçü, yetersiz analjezi ve istenmeyen spinal blok gibi riskler taşır. Bu deneysel çalışmada, tarafımızca geliştirilen yeni bir sabitleme cihazı ile epidural kateter sabitlemesinde kullanılan geleneksel sütür yöntemi karşılaştırılmıştır.
Gereç ve Yöntem: Ege Üniversitesi Teknopark CND ARGE tarafından geliştirilen Epilock® cihazının prototipi, Polilaktik Asit Termoplastik Polimer (PLA+) kullanılarak üç boyutlu yazıcıda üretilmiştir.
Etik kurul onayı sonrasında, 10 Sprague Dawley sıçanı (5 dişi, 5 erkek) anestezi altında rastgele iki gruba ayrılmıştır. Kontrol grubunda (n=5) epidural kateterler, ipek sütürlerle (20 düğüm) derinin 11 cm altına sabitlenmiştir. Deney grubunda (n=5) ise kateterler Epilock® cihazı ile sabitlenmiştir. Kateter sabitleme süresi kaydedilmiş, kateter stabilitesi ve enfeksiyon açısından sıçanlar 7 gün boyunca izlenmiştir.
Bulgular: Kontrol grubunda ortalama kateter sabitleme süresi 258 ± 250 saniye iken, deney grubunda 175 ± 150 saniye bulunmuştur. Epilock® cihazının kateter sabitleme süresini istatistiksel olarak anlamlı şekilde azalttığı gösterilmiştir (p=0,032). Kateter kalış süreleri karşılaştırıldığında, deney grubunda kateterler ilk günde anlamlı derecede daha uzun süre yerinde kalmıştır (p=0,048). Ancak ikinci günde anlamlı fark saptanmamıştır (p=1,000).
Sonuç: Epilock® cihazı, geleneksel sütür yöntemine kıyasla daha kısa işlem süresi ve daha iyi erken dönem kateter retansiyonu sağlamıştır. Bu bulgular, özellikle pozisyon vermede zorluk yaşayan hastalarda konforun artırılmasına katkı sağlayabilir. Güvenli ve pratik bir alternatif olarak öne çıkan cihazın, gerekli geliştirmeler ve geniş kapsamlı klinik çalışmalarla rutin kullanımda önemli bir seçenek olabileceği düşünülmektedir.
Anahtar Kelimeler
Etik Beyan
Bu çalışma Ege Üniversitesi Hayvan Deneyleri Yerel Etik Kurulu tarafından onaylanmıştır (Belge Numarası: 25.06.2025 tarihli 2025-025). Tüm yöntemler ilgili kurallara ve düzenlemelere uygun olarak yürütülmüştür. Çalışma Helsinki Bildirgesi'nde (1964) belirtilen ilkelere göre yapılmıştır.
Destekleyen Kurum
Bu deneysel çalışma, Ege Üniversitesi Teknopark bünyesinde faaliyet gösteren CND Ar-Ge tarafından desteklenmiştir.
Kaynakça
- Tripathi M, Pandey M. Epidural catheter fixation: subcutaneous tunnelling with a loop to prevent displacement. Anaesthesia. 2000 Nov;55(11):1113–6.
- McLeod G, Davies H, Munnoch N, Bannister J, MacRae W. Postoperative pain relief using thoracic epidural analgesia: outstanding success and disappointing failures. Anaesthesia. 2001 Jan;56(1):75–81.
- Königsrainer I, Bredanger S, Drewel-Frohnmeyer R, Vonthein R, Krueger WA, Königsrainer A, et al. Audit of motor weakness and premature catheter dislodgement after epidural analgesia in major abdominal surgery. Anaesthesia. 2009 Jan;64(1):27–31.
- van Kassel MN, Hermanides J, Lirk P, Hollmann MW. Prevention of Epidural Catheter Migration and Inflammation by Tunneling: A Systematic Review and Meta-Analysis. J Clin Med. 2025 Aug 15;14(16):5788.
- Bomberg H, Kubulus C, Herberger S, Wagenpfeil S, Kessler P, Steinfeldt T, et al. Tunnelling of thoracic epidural catheters is associated with fewer catheter-related infections: a retrospective registry analysis. Br J Anaesth. 2016 Apr;116(4):546–53.
- Gautam S, Agarwal A, Das PK, Khuba S, Kumar S. Prevention of epidural catheter migration: a comparative evaluation of two tunneling techniques. Korean J Anesthesiol. 2020 July 16;74(1):59–64.
- Su J, Soliz JM, Popat KU, Gebhardt R. Complications of Postoperative Epidural Analgesia For Oncologic Surgery: A Review of 18,895 Cases. Clin J Pain. 2019 July;35(7):589–93.
- Bishton IM, Martin PH, Vernon JM, Liu WH. Factors influencing epidural catheter migration. Anaesthesia. 1992 July;47(7):610–2.
- Rosero EB, Joshi GP. Nationwide incidence of serious complications of epidural analgesia in the United States. Acta Anaesthesiol Scand. 2016 July;60(6):810–20.
- Rawal N. Epidural analgesia for postoperative pain: Improving outcomes or adding risks? Best Pract Res Clin Anaesthesiol. 2021 May 1;35(1):53–65.
- Sharma A, Parasa SK, Tejvath K, Ramachandran G. Epidural catheter fixation. A comparison of subcutaneous tunneling versus device fixation technique. J Anaesthesiol Clin Pharmacol. 2016;32(1):65–8.
- Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144–54.
- Duffy BL. Securing epidural catheters. Can Anaesth Soc J. 1982 Nov;29(6):636–7.
- Anilakumari D, Singla D, Agarwal A, Kumari R. Comparative efficacy of MicroporeTM surgical dressing, TegadermTM and Lockit plus® for lumbar epidural catheter fixation in children: a prospective parallel group randomized controlled trial. Rev Esp Anestesiol Reanim. 2023 Oct;70(8):429–37.
- Clark MX, O’Hare K, Gorringe J, Oh T. The effect of the Lockit epidural catheter clamp on epidural migration: a controlled trial. Anaesthesia. 2001 Sept;56(9):865–70.
- Chadwick VL, Jones M, Poulton B, Fleming BG. Epidural catheter migration: a comparison of tunnelling against a new technique of catheter fixation. Anaesth Intensive Care. 2003 Oct;31(5):518–22.
Developing a device model for a safe and effective method in catheter fixation: An experimental study
Öz
Aim: Current permanent catheter fixation techniques may lead to epidural catheter dislodgement or extrusion, resulting in risks such as catheter migration, inadequate analgesia, and unintended spinal block. This study aimed to compare a newly developed fixation device with the conventional suture method used for epidural catheter fixation.
Materials and Methods: The Epilock® device, developed at Ege University Technopark CND ARGE, was manufactured using Polylactic Acid Thermoplastic Polymer (PLA+) material via a 3D printer. After obtaining ethical approval, 10 Sprague Dawley rats (5 males, 5 females) were anesthetized and randomly allocated into two groups. In the Control Group (n=5), epidural catheters were fixed 11 cm beneath the skin with silk sutures (20 knots). In the Experimental Group (n=5), catheters were secured using the Epilock® device. Fixation time was recorded, and the rats were monitored for catheter stability and infection for 7 days.
Results: In the Control Group (n=5), the mean catheter fixation time was 258 ±250 seconds, while in the Experimental Group (n=5) it was 175 ±150 seconds. The Epilock® device significantly reduced fixation time compared the Control Group (p=0.032). Catheters remained significantly longer in place in the Experimental Group on the first day (p=0.048), whereas no significant difference was found on the second day (p=1.000).
Conclusion: The Epilock® device provided a shorter procedure time and improved initial catheter retention compared with conventional suturing. These findings suggest it may enhance patient comfort, especially for those with positioning difficulties, and has the potential to be a valuable option in routine practice with further development and larger studies.
Anahtar Kelimeler
epidural catheter catheher fixation catheter adverse effects
Etik Beyan
This study was approved by the Ege University Local Ethics Committee for Animal Experiments (Document Number: 2025-025, dated June 25, 2025). All methods were conducted in accordance with relevant guidelines and regulations. The study was carried out in compliance with the principles outlined in the Declaration of Helsinki (1964).
Destekleyen Kurum
This experimental study was supported by CND R&D, operating within Ege University Technopark
Kaynakça
- Tripathi M, Pandey M. Epidural catheter fixation: subcutaneous tunnelling with a loop to prevent displacement. Anaesthesia. 2000 Nov;55(11):1113–6.
- McLeod G, Davies H, Munnoch N, Bannister J, MacRae W. Postoperative pain relief using thoracic epidural analgesia: outstanding success and disappointing failures. Anaesthesia. 2001 Jan;56(1):75–81.
- Königsrainer I, Bredanger S, Drewel-Frohnmeyer R, Vonthein R, Krueger WA, Königsrainer A, et al. Audit of motor weakness and premature catheter dislodgement after epidural analgesia in major abdominal surgery. Anaesthesia. 2009 Jan;64(1):27–31.
- van Kassel MN, Hermanides J, Lirk P, Hollmann MW. Prevention of Epidural Catheter Migration and Inflammation by Tunneling: A Systematic Review and Meta-Analysis. J Clin Med. 2025 Aug 15;14(16):5788.
- Bomberg H, Kubulus C, Herberger S, Wagenpfeil S, Kessler P, Steinfeldt T, et al. Tunnelling of thoracic epidural catheters is associated with fewer catheter-related infections: a retrospective registry analysis. Br J Anaesth. 2016 Apr;116(4):546–53.
- Gautam S, Agarwal A, Das PK, Khuba S, Kumar S. Prevention of epidural catheter migration: a comparative evaluation of two tunneling techniques. Korean J Anesthesiol. 2020 July 16;74(1):59–64.
- Su J, Soliz JM, Popat KU, Gebhardt R. Complications of Postoperative Epidural Analgesia For Oncologic Surgery: A Review of 18,895 Cases. Clin J Pain. 2019 July;35(7):589–93.
- Bishton IM, Martin PH, Vernon JM, Liu WH. Factors influencing epidural catheter migration. Anaesthesia. 1992 July;47(7):610–2.
- Rosero EB, Joshi GP. Nationwide incidence of serious complications of epidural analgesia in the United States. Acta Anaesthesiol Scand. 2016 July;60(6):810–20.
- Rawal N. Epidural analgesia for postoperative pain: Improving outcomes or adding risks? Best Pract Res Clin Anaesthesiol. 2021 May 1;35(1):53–65.
- Sharma A, Parasa SK, Tejvath K, Ramachandran G. Epidural catheter fixation. A comparison of subcutaneous tunneling versus device fixation technique. J Anaesthesiol Clin Pharmacol. 2016;32(1):65–8.
- Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144–54.
- Duffy BL. Securing epidural catheters. Can Anaesth Soc J. 1982 Nov;29(6):636–7.
- Anilakumari D, Singla D, Agarwal A, Kumari R. Comparative efficacy of MicroporeTM surgical dressing, TegadermTM and Lockit plus® for lumbar epidural catheter fixation in children: a prospective parallel group randomized controlled trial. Rev Esp Anestesiol Reanim. 2023 Oct;70(8):429–37.
- Clark MX, O’Hare K, Gorringe J, Oh T. The effect of the Lockit epidural catheter clamp on epidural migration: a controlled trial. Anaesthesia. 2001 Sept;56(9):865–70.
- Chadwick VL, Jones M, Poulton B, Fleming BG. Epidural catheter migration: a comparison of tunnelling against a new technique of catheter fixation. Anaesth Intensive Care. 2003 Oct;31(5):518–22.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Anesteziyoloji |
| Bölüm | Araştırma Makalesi |
| Yazarlar | |
| Gönderilme Tarihi | 7 Ekim 2025 |
| Kabul Tarihi | 27 Ekim 2025 |
| Yayımlanma Tarihi | 9 Mart 2026 |
| DOI | https://doi.org/10.19161/etd.1795301 |
| IZ | https://izlik.org/JA67WL73ZR |
| Yayımlandığı Sayı | Yıl 2026 Cilt: 65 Sayı: 1 |
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