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Eur J Vasc Endovasc Surg (2010) 39, 774e778

Pain Management in Peripheral Arterial Obstructive
Disease: Oral Slow-Release Oxycodone Versus
Epidural L-Bupivacaine
B.G. Samolsky Dekel a,*, R.M. Melotti a, M. Gargiulo b,
A. Freyrie b, A. Stella b, G. Di Nino a

a
Department of Surgery and Anaesthesiology Sciences, Head Prof. GF Di Nino, Anaesthesiology Section,
University of Bologna, Via Massarenti 9, 40138 Bologna, Italy
b
Department of Surgery and Anaesthesiology Sciences, Head Prof. GF Di Nino, Vascular Surgery Section,
University of Bologna, Bologna, Italy

Submitted 5 December 2009; accepted 23 February 2010
Available online 23 March 2010

KEYWORDS Abstract Objectives: To compare the effectiveness of oral slow-release oxycodone (group
Pain management; OX, n Z 18) with that of epidural L -bupivacaine (group LRA, n Z 13) for the control of
Peripheral Arterial moderate/severe pain of advanced-stage peripheral arterial obstructive disease (PAOD)
Obstructive Disease; patients.
Epidural; Design: Observational and retrospective analysis of advanced stage and hospitalised PAOD
Opiates; patients treated for pain management for at least 7 days prior to surgery or discharged from
Oxycodone the hospital without surgery.
Methods: The outcome measures were pain intensity using the visual analogue scale under static,
(VASs) and dynamic (VASd) conditions; vital signs, treatment side effects and patient satisfaction.
Results: In both groups, pain control was satisfactory and VAS scores median were VASs < 3 and
VASd < 4; under dynamic conditions, pain control was better in the LRA group (p < 0.01). Against
few and transient side effects, most patients (n Z 30) found both pain treatments good or excellent.
Results should be confirmed by studies with larger samples.
Conclusions: In the perioperative setting, the epidural infusion of local anaesthetics, such as L-bu-
pivacaine, is an effective technique for pain control in PAOD patients; for patients with contraindi-
cation for this technique or for non-surgical or outpatients, slow-release oxycodone is suggested as
a possible alternative for the control of severe pain in these patients.
ª 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

* Corresponding author. Tel.: þ39 051 6363087; fax: þ39 051 6364333.
E-mail address: boaz.samolskydekel@unibo.it (B.G. Samolsky Dekel).

1078-5884/$36 ª 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejvs.2010.02.016

It the evaluations and the applied treatments are recorded in primarily affects the adult male population and is often the APS database. imagine’)] both under static (VASs.e. heart rate (HR). by the APS may report hot burning or stabbing sensations of various team. the oral have to undergo major amputation. hypertension. individuals in Europe and in North America will suffer from codeine or tramadol associated or not with paracetamol) PAOD in the following years. intermittent claudication at various ment for at least 7 days prior to surgery or to hospital limb levels and at various walking distances. respiratory rate (RR). post-operatively.25% up to 3 times in 24 h (group advanced stage negatively affects the patient’s quality of life LRA) or an oral tablet of the association of oxycodone 5 mg (QOL) and the consequent incapacity induces serious clinical. Pain management objectives were to maintain treatment for PAOD patients is essential. patients (3 e4 stage of Fontaine) >18 years of age.2 Epidemiological forecasts claim that 27 million of pain. during limb disease and its sequels. were hospitalised in the vascular individuals older than 40 years to 35% in those older than 85 surgery ward and reported moderate-to-severe lower limb years. tion of the pain management treatment. About 25% of the The APS pain management protocols for such patients patients with intermittent claudication will deteriorate were the epidural administration of 4 ml L-bupivacaine 0. in the hypoaesthesia. Such feelings are almost exclusively located at the periodically monitored by the pain management outpatient anterior part of the foot (sometimes at the forefoot) and are office. such as sedation the patient’s denial. we also recorded non-invasive arterial blood pressure systemically or the use of loco-regional analgesia (LRA) (AP).Pain Management in PAOD 775 Peripheral arterial obstructive disease (PAOD) of the lower pain evaluation 3 times daily and the prescription and the limbs is a frequent multifactorial condition that progres. in some discharge without surgery. The prevalence of PAOD increases with age from 4. itching or constipation. signs of neurological or cardiac local anaes- presence of anatomical barriers at the vertebral column or thetic toxicity. patient tiveness of the administration of oral slow-release satisfaction was estimated before hospital discharge or oxycodone with that of LRA for the control of moderate.5 Symptoms of PAOD at bolus of 4 ml L-bupivacaine 0. an epidural catheter is contraindicated in patients expected side effects were motor block. which was not controlled by mild opiates (i. at other times. cient. associated with smoking. hyposthenia or with impaired coagulation and platelet aggregation. All participants were personally and participate in the daily rounds of these wards and also thoroughly informed by the ward and the APS physicians on deliver pain management assistance to surgical or non. ments. patient lies still on the Besides specific therapeutic approach to the underlying bed) and under dynamic conditions (VASd. in the Study of Pain (IASP) Guidelines for Pain Research in particular. and. respiratory depression. up to six times in 24 h (group OX).1. a feeling until hospital discharge without surgery. patients went surgery were followed. In case of poor symptoms other than intermittent claudication: moderate to pain control. nausea.6e8 When pain becomes continuous the moment of application of pain treatment until surgery or and associated with pre-atrophic and atrophic signs.3 Symptoms may include deficit and who were taken in hand by the APS for pain manage- of the sexual function. diabetes. surgery using a 4-item category scale: insufficient. The purpose of this study was to compare the effec. is not always feasible.4 administration of slow-release Oxycodone with the initial About 50% of the patients with PAOD complained of dose of 10e20 mg twice daily (group OX). (using the Ramsey 5-item scale). the prescribed rescue doses were an epidural severe pain is the most frequent. good or excellent. social and economic costs. vomiting. All sively gives rise to ischaemic pain of the affected limb. ischae. Methods Ethics This observational and retrospective study was based on The study was a routine activity and therefore no specific the analysis of data stored at the acute pain service (APS) authorisation and approval were required from the Hospital database and from the patients’ clinical charts. or opiates side effects. in the presence of contraindica- the administration of vasoactive drugs and about 2% will tions for the positioning of an epidural catheter. monitoring of invasive or non-invasive pain treatments. cases.9 it is evident that aggressive pain movement). The study was conducted according to run by an anaesthesiology consultant and residents and its the Helsinki declaration and the International Association for activity is integrated with that of the surgical wards and. with that of vascular surgery. who. and the degree of patient satisfac- however. suffi- to-severe pain of advanced-stage PAOD patients. were intensity. Besides long-term treat. .25% further. Severe chronic pain intensity within VASs  3 and VASd  4. At the same pain treatment should include strong opiates10 given time. the applied pain management regimen and gave informed surgical patients with pain. associated with dystrophic signs of progressive aggravation of Pain intensity was evaluated using the visual analogue the arterial insufficiency known as ‘evolved intermittent scale [VAS. Finally. while those who were discharged without surgery.3% of over a period of 1 year. This assistance includes both consent. and paracetamol 325 mg. The APS is Ethics Committee. especially among individuals who The intensity of pain was evaluated three times daily from are at a productive age.. In particular. Inclusion criteria in the study were advanced-stage PAOD mic coronary disease and carotid artery atherosclerosis. severe pain at rest and gangrene. Pain management of constraint and annoying cramping of increasing intensity is continuity was guaranteed to all patients: those who under- located in the ischaemic muscles. the presence of techniques via the epidural route. APS members Animals and Humans. The epidural route treatment side effects. 0 (‘no pain’) to 10 (‘most intense pain I can claudication’. 5% will require treatment of revascularisation or every 6 h (group LRA) or.

In group LRA. 0. In group OX. Alternatively. Often. 2. 0. patients.0).0.0) and that of Pain management in PAOD patients with severe ischae- VASd was 3. group LRA (n Z 13) and group OX (n Z 18) radiofrequency lumbar sympathetic block and electrical patients were identified and included in the study. nociceptive pain) and Table 1 Demographic characteristics.0) and that of VASd was 3. Finally. In group OX. operator experience and comfort groups were homogeneous. were reported as median. Cary. SR..25% boluses were increased from 4 to 5 ml nociceptors due to tissue lesion (i. like that of PAOD patients. a variable association of sensory. L. Data Presentation and Statistical Analysis (12. relationship between the extension of the tissue lesion and Rescue dose was administered in five patients (n Z 3 in pain intensity. yet score of VASs was 2. the median analgesia under static conditions and to lesser extent. only one patient reported transient to relieve pain or restore function. Group n Female/ Age Fontain stage Analgesia applied Clinical result Male n Mean III IV Main treatment Rescue dose Surgery Discharge (SD) LRA 13 3/10 74. nZ7 nZ6 (9.0 with ‘non-surgical’ pain management modalities or epidural (interquartile range. oral slow-release oxycodone may provide optimal 4.3) Oxycodone paracetamol 375 mg IR) SR Daily max 6 times/24 h mean dose: 27.0 and 3. twice daily.01. 1. bid. IR. range.5 mg). (2) a personal and subjective experience with group LRA and n Z 2 in group OX). it is generally accepted that these conditions. the applied pain treatment and the clinical outcomes vasospastic component. 5% and 95% centiles and range. for long- 2.0e8. modalities.4 nZ4 nZ9 Epidural boluses: L-Bupivacaine 0.3 nZ6 n Z 12 OS bid: (Oxycodone 5 mg þ nZ8 n Z 10 (6. treat.0 (interquartile range. interquartile range.25% 4 ml/6 h OX 18 3/15 73.5) L-Bupivacaine max 3 boluses/24 h 0.0e9.25% 4 ml. pain treatment and clinical outcomes split by the study groups. 0. USA). level influence the selection of one of these expensive Figure 1 shows box and whisker plots of the median. These modalities tend to be effec- shows these patients’ demographic characteristics. pain control was better in the LRA group patients are as much concerned by QOL as by life expec- (P < 0. Table 1 spinal-cord stimulators. 1.7) . 5% and 95% centiles. 5% and 95% mic pain of the lower limbs is scantily addressed. 0.e. Our findings suggest that epidural analgesia with interquartile range and range of the VAS scores during the 21 boluses of L-bupivacaine provides robust pain relief under pain evaluations. one Chronic severe pain.0 (interquartile range.. Samolsky Dekel et al. Except for the pain treatment used. Fontain tive in and indicated for ischaemic conditions with a major stage. range.0e2.0 and analgesia. oral. range. immediate release. Fontain stage. 2. is char- patient reported lower limb hypoaesthesia and hyposthenia acterised by three elements: (1) lack of direct or exclusive in the first 4 h after the positioning of the epidural catheter.0e5.0e9. most patients (n Z 30) found the applied All analyses were conducted using StatView for Windows pain treatment good or excellent and only one patient (SAS Institute Inc. the median score of VASs was both static and dynamic conditions. respectively. in group LRA. under dynamic conditions. OS. Statistical significance was defined as P < 0.0.8 n Z 10 n Z 21 n Z 15 n Z 16 (7.01). patients’ compliance. Pain management in the growing substantial population of patients with PAOD is a major issue both in the perioperative Results setting and for outpatients. 2.G. 5% and 95% centiles.0. slow release.0.776 B. emotional and cognitive ment was hence optimised as follows: in the LRA group. particularly with regard to chronic diseases for which Treatment side effects were relatively rare in both the aim of therapy is not only to treat the disease but also groups. factors.0 and term treatments and for patients who cannot be treated 3. respectively. in the OX group. When groups were observed under dynamic conditions as. respectively. 0. and (3) the concomitant activation of peripheral bupivacaine 0. In these patients. range.0 (interquartile range and 5% and 95% satisfactory. ‘Non-surgical’ pain management modalities for these patients may include neurolytic or Over 1 year.0). 0. Differences between VAS scores were Discussion analysed using a paired t-test. centiles. tancy. In these centiles.0e10.0. under making medical decisions. Pain intensity scores described it as sufficient.0.2) mg Total 31 6/25 73. respectively. of both groups. NC. the daily dose of oxycodone was doubled.8 (12. the two availability of technology.8 (<24 h) somnolence (Ramsey scale 2e3).0e3. the two major objectives of treatment are: (1) to Statistically significant differences between the two prevent ischaemic attacks and (2) to improve QOL.0.0 and 6.

especially by the at equal analgesic doses. interquartile range and range of the VAS scores during the 21 pain evaluations.Pain Management in PAOD 777 Figure 1 Box and whisker plots of the median. LRA group under dynamic conditions and (2) the statistical caine. pulmonary.19 Morphine is logical responses and postoperative organ dysfunction. but does not twice a day. *P < 0. priate diagnosis and monitoring. Evidence shows mobilisation is important to accelerate postoperative that opiates give good response rate in nociceptive and recovery. disposability. for the treatment of acute and chronic pain. sleep doses before signs of systemic toxicity occur. epidural anal. work overdosing or unintended intravascular injection. the study results may be considered sufficient to complications16 as during LRA. Further . pain causes alterations in patients’ family. to diabetic neuropathies. L-Bupivacaine appear to be satisfactory with the only advantage for the has been developed to offer a safer alternative to bupiva. reduced cardiovascular toxicity or only minimal signs of cardiac effects self-esteem and negative feelings.e. but also in no and sexual activities and leads to changes in mood.12 characterised not only in higher plasma concentrations and Chronic severe pain compromises physical activity. With appro- endocrine.21 In the epidural or high doses of opiates may improve some cardiac present study.11 individuals. titration to higher doses was based on the change the incidence of severe cardiac complications in rescue dose consumption in 24 h. nature and the small sample size.18 and leisure relationships. set to assess and manage risk and titration. Such limitations impose gesia can improve clinical outcome by preventing the caution before taking the study’s results as definitive. clinical outcome and potentially shorten the hospital stay. The intensity and frequency of Guidelines for chronic pain management consider pain may exceed its function as a protective indicator opiate medications as effective analgesics with a well- and may seriously compromise the QOL of affected established role in the management of severe pain. may be associated with reduction in inci.13e15 side effects and the ability to control painful diabetic Epidural analgesia using local anaesthetics is the best tech. etc. considered as the gold standard of opiate prescription for assist postoperative nursing and physiotherapy. oral slow-release oxycodone. having the desirable blocking properties of racemic difference between the groups was of high significance bupivacaine with a greater margin of safety due to its reduced (P < 0. physio. is thought to have a better bio- epidural route. in after central nervous system toxicity occurs in case of either addition. strongly supported by animal and volunteer studies. Potent postoperative analgesia. such as despair.01.20 Evidence shows that post-retropubic nique for decreasing postoperative stress after lower prostatectomy pain control with oral slow-release oxy- abdominal or lower limb surgery.01). but employed effectively with other management techniques also may minimise perioperative stress response. In PAOD patients. In particular. neuropathic pain). L-bupivacaine provides a long- (i. coagulation. warrant further prospective and randomised studies to verify thesia. eventually. unlike during general anaes. fewer itching. patients with pre-existing high cardiac risk.). the initial dose of oxycodone was 10e20 mg variables such as tachycardia and ischaemia. This is eral nervous system lesions due to the frequent ischaemia particularly useful when recovery of motor function and early and. they are tools that can be Pain alleviation not only improves patients’ comfort. Analgesia using either codone is preferable to epidural analgesia. hallucinogenic and other dence and severity of many perioperative dysfunctions.11. gastrointestinal. It is cancer origin. central nervous system. compared to oral morphine.6e8 These potent medications require a thorough under- Physiological responses to postoperative pain may alter standing of their risks and benefits. thus limiting the risk of type II error. neuropathies. enhance severe pain. the fibrinolytic system is not inhibited. Among the newer available opiates.. we used L-bupivacaine for LRA. The reduced toxic potential of L-bupivacaine is neuropathic pain states in patients with chronic pain of non. development of arterial or venous thrombo-embolic However. For patients The main limitations of the study are its retrospective undergoing vascular or orthopaedic surgery.17 the generalisation of the findings as (1) both treatments In this study. along with a basic skill organ functions (cardiovascular. the aberrant activity or pathology of the nervous system toxic potential. differentiation between sensory and motor blocks. both types of pain lasting block with a clinical profile characterised by a fine may co-exist given the presence of both tissue and periph.

Shemanski L. toxi- history of intermittent claudication. Scand J Urol peripheral arterial obliterative disease treated with ifenprodil Nephrol 2006. Epidural pain relief versus of cardiovascular disease and mortality in the Cardiovascular systemic opioid-based pain relief for abdominal aortic surgery. arterial disease: type D personality and severity of periph. Conflict of Interest Jensen TS.v. Arterioscler Thromb. Akre O.40:192e7. Moulin D. Cardiol as L-bupivacaine. Tornblom M. Olin JW. Ballantyne JC. Manolio TA. 13 Jayr C. 286:1317e24. a strong opiate with Manage 1992. Meinert CL. J Pain Symptom outpatients and for long treatments. Gustafsson O. Drugs 1998. non-surgical or patients with chronic nonmalignant pain. Anesth. Br J Anaesth 1998. Evaluation of the impact of peripheral obliterative literature. the epidural infusion of local anaesthetics. Pain All authors disclose no financial and personal relationships 1999. Bensen W. Andersen G. Ann Vasc Surg 1989. Health Study. Vasc Biol 1999.7:69e77. Passa P. Anesthesia Trial Study Group. Lecasble M. oxycodone hydrochloride versus epidural anaesthesia for pain 7 Marquis P. JAMA 2001.56(Suppl. Gordon A. awareness. abdominal surgery in high-risk patients. Controlled-release oxycodone relieves neuropathic pain: health-related quality of life in patients with peripheral a randomized controlled trial in painful diabetic neuropathy. 96:548e54. Tryba M. with other people or organisations that could inappro.83:85e90.G. such as oral slow. and treatment in primary care. Drugs 1998. et al. double-blind. The Cardiovascular Health Study Group. Cochrane Database Syst Rev 2006. Thomson GT. 12 Sindrup SH. In the perioperative setting. Erlinger TP. peripheral arterial disease in the United States: results from the 15 Peyton PJ. et al. Poor et al. 37e48. may be further studied as a valid Babul N. 3 Belch JJ. control of pain in PAOD patients. 6 Aquarius AE.56(Suppl. Pain 2003. Med Rehabil 2008. a known anti-neuropathic pain activity. Myles PS. pain control and risks in long-term opioid treatment. Treat-Jacobson D. Tramadol relieves pain and allodynia in poly- neuropathy: a randomised. de Vries J.46:507e12. Critical issues in peripheral arterial disease randomized to epidural or general anesthesia for lower detection and management: a call to action.105:71e8. Continuous epidural infusion of ropivacaine for postoperative analgesia after major abdominal surgery: comparative study with i. Prevalence of and risk factors for to treatment. Madsen C. 9 Aronow WS. 1999e2000.79:422e34. Watt-Watson J. Califf RM. Agnelli G. 5 Hirsch AT. Bergenwald L. ropivacaine and levobupivacaine. Acta Biomed 2008. Parsons R. Gustafsson U. 4 McDaniel MD. Plaud B. Polak JF. Cushman M. Smith T. Rosenthal LJ. Anesthesiology 1993. Arch Intern Med extremity vascular surgery. Leteurnier Y. Basic data related to the natural 18 Leone S. National Health and Nutrition Examination Survey. controlled release codeine in the treatment of osteoarthritis of the hip or knee. 3):25e35. Ann Fr Anesth Reanim 1998. controlled trial. 273e7. and clinical use of new long acting local anesthetics. Harsanyi Z. Brosen K.163:884e92. for patients 10 Zenz M. release oxycodone.89:S77eS82. et al. Mittelmark M.13:61e8. Results of an ARTEMIS study. is an effective analgesia technique for the Rev 2005.19:538e45. 3): major complications of each treatment modality. Perioperative morbidity in patients Clement DL. 19 Gallagher RM. in accordance with the 8 Marquis P. Strumpf M. 20 Watson CP. benefits attending 1 Selvin E. Topol EJ. J Vasc Surg 21 Hohwu L.17:540e54. PCA morphine.3. Pharmacology. Bertrand M. Samolsky Dekel et al. et al. et al. Gottlieb SO. CD005059. 2 Newman AB.778 B. Cronenwett JL. Peripheral arterial disease detec. et al. Perioperative epidural analgesia and outcome after major Circulation 2004. Denollet J. 14 Jayr C. Regensteiner JG. alternatively. Beattie C.79:92e105. Eisenhoffer J. Analg. Low JH. Ankle-arm index as a predictor 16 Nishimori M. Chronic pain and opiates: balancing Creager MA. 17 Christopherson R. References 81:887e92. et al. Nathan N. Arch Phys tion. Hamming JF. 2003. eral arterial disease as independent predictors.3: cology. Bellamy N. investigation should address also the issue of side effects and tartrate. Criqui MH. priately influence (bias) this work. 11 Peloso PM. et al. Casati A. Double blind randomized placebo control trial of choice for the control of severe pain in PAOD patients.110:738e43. Fanelli G. Long-term oral opioid therapy in with contraindication for this technique. Norris EJ. et al. Beaussier M. Repercussion of postoperative pain. . Quality of life of patient with control after radical retropubic prostatectomy. Oral 2007. Di CS. Management of peripheral arterial disease. Perioperative Ischemia Randomized 2003.27:764e71. such arteriopathy on quality of life. J Rheumatol 2000. Frank SM. Silbert BS. Rigg JA. Jamrozik K.