SAFETY AND EFFICACY OF CONTINUOUS SPINAL ANESTHESIA USING SPINOCATH FOR MAJOR GENITOURINARY SURGERY Thesis. Under the supervision of

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1 SAFETY AND EFFICACY OF CONTINUOUS SPINAL ANESTHESIA USING SPINOCATH FOR MAJOR GENITOURINARY SURGERY Thesis Submitted for Complete fulfillment of the degree of M.D. in Anesthesiology By Ahmed Abdella Mohammed Abd El-Rahman (M.B.B.Ch, M.Sc.) Under the supervision of Prof. Dr. Ashraf Mohamed Mohsen Professor of Anesthesiology Faculty of Medicine, Cairo University Prof. Dr. Saher Ali Marzouk Professor of Anesthesiology Faculty of Medicine, Cairo University Dr. Ahmed Abdel-Aziz Aref Assistant Professor of Anesthesiology Faculty of Medicine, Cairo University Dr. Nazmy Edward Saif Lecturer of Anesthesiology Faculty of Medicine, Cairo University Faculty of Medicine Cairo University 2012

2 Abstract Continuous spinal anesthesia (CSA) is the technique of producing and maintaining spinal anesthesia with small doses of local anesthetic which are injected repeatedly as required into the subarachnoid space via an indwelling catheter. Continuous spinal anesthesia (CSA) combines the advantages of single dose spinal anesthesia; rapid onset and a high degree of success, with those of a continuous technique. CSA produces effective sensory and motor blockade and has a short recovery period. Spinocath provides the anesthesiologist with accurate feedback. The pronounced dural click, and the visual check of CSF flashback in a second, confirming the intrathecal catheter position. Key Words: History, Anatomical Considerations in Neuraxial Blockade, Physiologic Effects of Central Neuraxial Blockade, The Most Commonly used CSA Kits

3 Acknowledgement First of all I want to thank GOD for supporting me and guiding me throughout my life I want to express my profound gratitude to Prof. Dr. Ashraf Mohamed Mohsen, Professor of Anesthesiology, Faculty of Medicine, Cairo University, for his most valuable advises, support and dedicating much of his precious time to accomplish this work. My special thanks to Prof. Dr. Saher Ali Marzouk, Professor of Anesthesiology. Faculty of Medicine, Cairo University, for her continuous encouragement, supervision and kind care. I am also grateful to Dr. Ahmed Abdel-Aziz Aref, Assistant Professor of Anesthesiology, Faculty of Medicine, Cairo University, for his unique effort, his insistence for perfection and his useful scientific support all through the whole work. I am also grateful to Dr. Nazmy Edward Saif, Lecturer of Anesthesiology, Faculty of Medicine, Cairo University, for his unique effort, his insistence for perfection and his useful scientific support all through the whole work.

4 List of Abbreviations CSA CSE CSF PDPH SSSA CPB IT MLAD NMDA PCA GABAB SVR DVT UFH aptt LMWH IONV FDA CES TNS : Continuous spinal anesthesia : Combined spinal epidural : Cerebrospinal fluid : Post-dural puncture headache : Single shot spinal anesthesia : Cardiopulmonary bypass : Intrathecal : Minimum effective local anesthetic dose : N-methyl-D-aspartate : Patient controlled analgesia : Gamma-amino-buteric acid receptor type B : Systemic vascular resistance : Deep vein thrombosis : Unfractionated heparin : Activated partial thromboplastin time : Low molecular weight heparin : Intra-operative nausea and vomiting : Federal drug administration : Cauda equina syndrome : Transient neurological symptoms

5 List of Figures Fig. Title Page Lemmon needle The Patient lying with the CSA needle protruding from his back Hingson Ferguson needle Tuohy needle Tuohy Flowers needle Cappe and Deutsch needle CSA needle with Protective Shield over Lumbar spine CSA needle metal protector Anatomy of the sacral hiatus and dorsum of the sacrum Normal curvature of the vertebral column A lumbar vertebra in (a) lateral and (b) antero-superior views Sagittal section of the lumbar region shows the spine s interspinous and supraspinous ligaments and ligamenta flava Spinocath catheter over needle Kit 27G Quincke Spinal needle with braided wire attached to it and catheter over both of them Passing the spinal needle through the dura Pulling on the wire to remove the needle from within the catheter Conventional catheter through needle design with CSF leaking from around the catheter Spinocath catheter over the needle design with the catheter sealing the dural puncture causing minimal CSF leak Portex Catheter through needle kit Scanning electron micrograph of a dural puncture hole made by a 25G Quincke (cutting) needle Scanning electron micrograph of a dural puncture hole made by a 25G Quincke (cutting) needle

6 Fig. Title Page Scanning electron micrograph of a dural puncture hole made by a 25G Whitacre (non-cutting) needle Scanning electron micrographs of sterile catheters Scanning electron micrographs of sterile catheters Human lamina arachnoid. Scanning electron microscopy Human spinal arachnoid trabecula. Trabecular arachnoid encircling motor and sensitive nerve roots at the entry site of nerve root cuffs Human spinal arachnoid trabecula encircling the spinal cord Diagram of a likely cause of temporary and permanent neurological complications following CSA The needle has passed the nerve (arrow) Looping of the catheter Age difference between the two groups Sex difference between the two groups ASA class difference between the two groups Base line mean arterial blood pressure Base line heart rate Pain intensity (VAS scale) Sensory level Degree of motor blockade Percentage changes in the mean arterial blood pressure (MAP) Severe hypotension Ephedrine dose Percentage changes in the heart rate Occurrence of bradycardia Atropine dose Post-dural puncture headache Total local anesthetic dose

7 List of Tables Table Title Page General comparison between the four types of Neuraxial blocks The main risk factors for hemodynamic instability during neuraxial anesthesia Demographic data Base line mean arterial blood pressure Base line heart rate Pain intensity (VAS scale) Sensory level Degree of motor blockade Percentage changes in the mean arterial blood pressure (MAP) Severe hypotension Ephedrine dose Percentage changes in the heart rate Occurrence of bradycardia Atropine dose Post-dural puncture headache Total local anesthetic dose

8 Contents Page Introduction.. 1 Aim of the Work 3 Review of Literature: History 4 Anatomical Considerations in Neuraxial Blockade Physiologic Effects of Central Neuraxial Blockade.. 21 The Most Commonly used CSA Kits 24 Indications and Advantages of CSA.. 36 Contraindications for Continuous Spinal Anesthesia 50 Complications of Continuous Spinal Anesthesia.. 55 Patients and Methods.. 82 Results 87 Discussion Conclusion. 113 Summary 115 References Arabic Summary..

9 Introduction INTRODUCTION Continuous spinal anesthesia (CSA) is the technique of producing and maintaining spinal anesthesia with small doses of local anesthetic which are injected repeatedly as required into the subarachnoid space via an indwelling catheter (Jaitly and Kumar, 2009). Continuous spinal anesthesia (CSA) combines the advantages of single dose spinal anesthesia; rapid onset and a high degree of success, with those of a continuous technique. CSA produces effective sensory and motor blockade and has a short recovery period (Jaitly and Kumar, 2009). Continuous spinal anesthesia has been used for operative anesthesia and post-operative analgesia as a safe technique with a more predictable effect and lesser hemodynamic and respiratory repercussions. Continuous spinal anesthesia (CSA) is an underutilized technique in modern anesthesia practice (Maurer et al., 2003). Compared to epidural anesthesia, CSA provides safer preoperative confirmation of catheter position, faster onset of action and more reliable blockade. Moreover, only 1/10 to 1/5 of anesthetic is required, resulting in a much lower risk of systemic toxic reactions. In contrast to single-dose spinal anesthesia, with CSA the anesthetic can be administered during the operation. Repeated dosing to prolong and control the duration and level of blockade is possible at any time, thereby improving overall anesthesia control. The block also subsides more rapidly. The risk of cardiovascular side effects and respiratory compromise is significantly reduced (Goulmamine and Kamran, 2005). A new catheter-over-needle design (Spinocath, B. Braun) has been developed to minimize problems and complications of continuous spinal 1

10 Introduction anesthesia with microcatheters (Imbelloni and Gouveia, 2006), which include difficult catheter insertion, failure of insertion, breakage, inadequate anesthesia, postdural puncture headache, and, rarely, development of cauda equina syndrome (De Andres et al., 1999). Spinocath features a unique catheter-over-needle design, the catheter is positioned over the spinal needle. After puncturing the dura mater the needle is withdrawn from the catheter, which simultaneously seals the hole in the dura. In this way, CSF (cerebrospinal fluid) leakage is prevented right at the start of the procedure, reducing the risk of postdural puncture headache (PDPH) to a minimum (Alonso et al., 2009). Spinocath provides the anesthesiologist with accurate feedback. The pronounced dural click, and the visual check of CSF flashback in a second, confirming the intrathecal catheter position (Goschl et al., 2005). CSA has been used in medically complicated patients (as in patients with respiratory failure) undergoing cardiac, vascular, orthopedic, and general surgeries. Many authors advocate general anesthesia with or without Epidural analgesia as first choice in fit patients undergoing abdominal procedures. While in selected patients undergoing surgeries on the lower extremities, perineum, groin and lower abdomen, who are living at the edge of their cardiovascular and respiratory physiological reserves and in whom general anesthesia is likely to increase morbidity and mortality, many authors advocate CSA as an alternative to general anesthesia (Benonis and Habib, 2008). 2

11 Aim of the Work AIM OF THE WORK The study was conducted on patients undergoing major genitourinary surgery expected to exceed 3 hours in duration to compare safety and efficacy of continuous spinal anesthesia using spinocath versus combined spinal epidural anesthesia. The clinical safety and efficacy evaluated by recording the pain intensity upper level of sensory blockade, quality of motor blockade, changes from the baseline mean arterial blood pressure and heart rate, occurrence of post-dural puncture headache and total dose of local anesthetic given to the patient. 3

Review of Literature HISTORY 1- CSA Needles: While most were striving to improve the design of Spinal needles to decrease the incidence of complications, some workers were looking at ways of

12 Review of Literature HISTORY 1- CSA Needles: While most were striving to improve the design of Spinal needles to decrease the incidence of complications, some workers were looking at ways of improving the technique of Spinal anesthesia to make it applicable to more surgical procedures. Dean had described a technique of continuous Spinal anesthesia in 1907 in which he left the Spinal needle in situ during surgery and injected more local anesthetic solution as and when necessary "exploring needle", but his technique was not widely accepted (Dean, 1907). Lemmon published a paper in 1940 describing a 17G and 18G Nickel/Silver alloy malleable needle and introducer with a sharp, medium-length, cutting bevel and a small opening in the long side of the bevel to enable free flow of CSF (Fig. 1) (Lemmon, 1940). The needle was placed in the subarachnoid space, was bent at the skin surface, and was attached to rubber tubing through which local anesthetic solution was injected when required. The patient lay on a mattress and table that had a hole placed so as to accommodate the protruding needle (Fig. 2). On the introduction of Stainless Steel, the needle was manufactured from Stainless Steel annealed to render it malleable (Lemmon, 1940). Fig. (1): Lemmon needle (Calthorpe, 2004). Fig. (2): The Patient lying with the CSA needle protruding from his back (Calthorpe, 2004). 4

13 Review of Literature In 1943, Hingson presented his modification of the Lemmon needle (Higson and Edwards, 1943). The distal and proximal portions of the needle were rigid, with an annealed middle portion that was malleable. The tip of the needle was a short-beveled point with a blunt cutting edge and an extra orifice near the tip. The hub had a reinforced steel collar to connect to small-bore tubing. There was a safety bead to prevent needle breakage (Fig. 3). Fig. (3): Hingson Ferguson needle (Calthorpe, 2004). Fig. (4): Tuohy needle (Calthorpe, 2004). The continuous Spinal needle had its problems and was technically difficult to use and keep in position. In 1944, Tuohy used a 15G directional Spinal needle through which he passed a Nylon Ureteric catheter into the subarachnoid space to allow continuous Spinal anesthesia (Tuohy, 1944). The needle had a fitted stylet with a matching bevel (Fig. 4). The medium length bevel had cutting edges. A year later, he published an article describing an adaptation of his needle to incorporate a "Huber tip", which allowed directional control of the catheter to point cephalad or caudal as required (Tuohy, 1945), Tuohy needle had a sharp inner edge to the bevel that caused shearing of catheters, so it was modified. Over the years, other modifications were made to the Tuohy needle. One modification was the Tuohy Flowers modification, with a shorter and blunter bevel and the stylet protruding beyond the bevel of the needle to ease insertion of the point through tough ligaments (Fig. 5). 5

14 Review of Literature Fig. (5): Tuohy Flowers needle (Calthorpe, 2004). Fig. (6): Cappe and Deutsch needle (Calthorpe, 2004). Following the introduction of the pencil-point needle for single-shot Spinal anesthesia, it was inevitable that a similar needle would be introduced for continuous Spinal anesthesia. Although Tuohy had already introduced the idea of continuous Spinal anesthesia using catheters rather than needles, the large Tuohy needles and catheters had a significant PDPH rate, so continuous Spinal needles were still in common use. Cappe and Deutsch described a malleable cone-tipped Spinal needle in It was 20G in diameter and had a Whitacre tip and an 18G introducer (Fig. 6). The middle portion had been annealed to render it malleable so that the needle could be bent at the skin surface once the tip was in the subarachnoid space. There was an adjustable needle stop to stabilize the needle. They reported a PDPH rate of 6.6% in their needle group compared to 22% in the conventional cutting-tip needle group (Cappe and Deutsche, 1953). Several devices have been invented to help protect the CSA needle while it is in the subarachnoid space like this shield (Fig. 7) that is made of Plexiglass with a central channel that accommodate the needle protecting it from dislodgment. Also, there was another device which was called "Bishop's hat" (Fig. 8) and was made of metal, it was used to protect the needle and the rubber tubing in case the special mattress for CSA wasn't available (Calthorpe, 2004). 6

Review of Literature Fig. (7): CSA needle with Protective Shield over Lumbar spine (Calthorpe, 2004). Fig. (8): CSA needle metal protector (Calthorpe, 2004).

incremental doses of local anesthetic. He reported no increase in the incidence of PDPH compared with single injection techniques and no neurological complications (Tuohy, 1944; Tuohy, 1945).

15 Review of Literature Fig. (7): CSA needle with Protective Shield over Lumbar spine (Calthorpe, 2004). Fig. (8): CSA needle metal protector (Calthorpe, 2004). 2- Large-Bore Catheters (Marco-Catheters): As mentioned, CSA was first described by Edward Tuohy in 1944 using a ureteric catheter via a 15G Huber point needle and initiating Spinal anesthesia with incremental doses of local anesthetic. He reported no increase in the incidence of PDPH compared with single injection techniques and no neurological complications (Tuohy, 1944; Tuohy, 1945). In 1950, Dripps reviewed reports on single-shot Spinal anesthesia (SSSA) and CSA with a malleable needle and catheter techniques. He found an 8% (43 of 506) incidence of failed anesthesia with CSA compared with 1.9% (37 of 1921) with SSA. Also, he found more technical difficulties with the catheter technique and a significantly higher incidence of transient parasthesia (33%) than with single injection techniques (13%). Over the next 25 years, CSA was not used much, as reflected by the paucity of references in the literature, and it is hard not to conclude that this was a direct result of Dripps article (Dripps, 1950). 7

16 Review of Literature Many studies were made later on CSA using large-bore catheters to detect the differences between it and the single-shot Spinal anesthesia in the technique and the complications (Brown, 1952; Giuffrida et al., 1972; Kallos and Smith, 1972; Rao and El-Etr, 1981; Denny and Selander, 1998). The PDPH incidence was found to be around 1% in the elderly population (Denny et al., 1987; Mahisekar et a., 1991; Liu et al., 1993; Cohen et al., 1994). Other studies were also made to compare it with the Epidural anesthesia reporting not only greater cardiovascular stability but a significantly lower failure rate than Epidural anesthesia (Rigler et al., 1991; Van Gessel et al., 1995; Hampl et al., 1996; Horlocker et al., 1997; Horlocker et al., 1997). 3- Micro-Catheters: The Spinal micro-catheter was described first by Hurley and Umbert (Hurly and Lambert, 1990). Their aim was to develop a sufficiently finebore catheter (32G) which could be threaded through an appropriately fine Spinal needle (26G) into the CSF. Theoretically, compared with large-bore catheters, this would enable CSA to be performed in younger patients with a reduced risk of PDPH. Their initial study with the 32G micro-catheter showed a 20% incidence of technical complications, similar experiences were also reported by others (De Anders et al., 1994). The 32G Spinal micro-catheter was difficult to handle, CSF could not be aspirated and it had a very high internal resistance, making injection of local anesthetic very slow. A 28G catheter which could be passed through a 22G Spinal needle was then developed (Kendall ). This catheter proved easier to use and did not have as many technical complications. Later studies with 28G catheters have shown a technical complication rate similar to that of large-bore 8

17 Review of Literature catheters, including the incidence of PDPH (Horlocker et al., 1997). However, it was not long before cases of neurological complications, in the form of Cauda-Equina syndrome, were described after CSA with microcatheters (Rigler, 1991). Further reports of problems with the microcatheter technique (Schell et al., 1991) led the FDA in 1992 to ban the use of Spinal catheters smaller than 24G in the USA, while it was used in the rest of the world (FDA Safety Alert, 1992). In all, approximately 12 cases of Cauda-Equina syndrome after CSA with micro-catheters have been reported (Thomas and Somayaii, 1998). 9

18 Review of Literature ANATOMICAL CONSIDERATIONS IN NEURAXIAL BLOCKADE The vertebral column: The spine is one of the most important parts of our body. The 3 main functions of the spine are: Protect the spinal cord, nerve roots and several of the body's internal organs. Provide structural support and balance to maintain an upright posture. Enable flexible motion. (Bridwell and Boachie, 2003) Regions of the spine: The spine is divided into 4 main regions; cervical, thoracic, lumbar and sacral. Each region has specific characteristics and functions (Okubadejo et al., 2005). - Cervical spine: This region consists of 7 vertebrae. These vertebrae protect the brain stem and the spinal cord, support the skull and allow for a wide range of head movement (Okubadejo et al., 2005). - Thoracic spine: Beneath the last cervical vertebra are the 12 vertebrae of the thoracic spine. The first thoracic vertebra (T1) is the smallest and the last thoracic vertebra (T12) is the largest. The thoracic vertebrae are larger than the cervical bones and have longer spinous processes. In addition, rib attachments add to the thoracic spine's strength. These structures make 10

19 Review of Literature the thoracic spine more stable than the cervical or lumbar regions. In addition, the rib cage and ligament systems limit the thoracic spine's range of motion and protect many vital organs (Klepps et al., 1999). - Lumbar spine: The lumbar spine has 5 vertebrae. The size and shape of each lumbar vertebra is designed to carry most of the body's weight. Each structural element of a lumbar vertebra is bigger, wider and broader than similar components in the cervical and thoracic regions. The lumbar spine has more range of motion than the thoracic spine, but less than the cervical spine (Prpa et al., 2004). The lumbar facet joints allow for significant flexion and extension movement as they are oriented somewhat parasagittally but limit rotation. Lumbar vertebrae also contain small mammillary and accessory processes on their bodies. These bony protuberances are sites of attachment of deep back muscles (Boelderl et al., 2002). The nearly perpendicular orientation of the spinous process in the lumbar area and the downward angular orientation in the thoracic area define the angle required for placement and advancement of a needle intended to access the vertebral canal (Drasner and Larson, 2007). - Sacral spine: The sacrum is located behind the pelvis. 5 bones fused into a triangular shape. The sacrum fits between the two hip bones connecting the spine to the pelvis. The last lumbar vertebra (L5) articulates with the sacrum. Immediately below the sacrum are 5 additional bones, fused together to form the coccyx (Fig. 9) (Bridwell and Boachie, 2003). 11

20 Review of Literature Fig. (9): Anatomy of the sacral hiatus and dorsum of the sacrum. - Spinal curves: The normal spine has S like curve when looking at it from the sagittal plane. This allows for an even distribution of weight. The cervical and the lumbar spines curve slightly inward, the thoracic and the sacral spines curve outward. Even though the lower portion of the spine holds most of the body's weight, each segment relies upon the strength of the others to function properly (Steven et al., 2008). The thoracic convexity (kyphosis) and the lumbar concavity (lordosis) are of major importance to the distribution of local anesthetic (LA) solution in the subarachnoid space (Fig. 10) (Drasner and Larson, 2007). 12

Continuous Spinal Anaesthesia

Continuous Spinal Anaesthesia Ph. Biboulet Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, Montpellier France CSA story : 1906 Dean 1944 Tuohy 1991 CSA revisited