Consensus and controversies in the definition, assessment, treatment and monitoring of BTcP: results of a Delphi study

Introduction. There is no unanimous consensus on the clinical features to define breakthrough cancer pain (BTcP). The current project aimed to investigate the opinion of a panel of experts on cancer pain on how to define, diagnose, assess, treat and monitor BTcP. Materials and methods. A two-round Spanish multi-centre exploratory Delphi study was conducted with medical experts (n = 90) previously selected from Medical Oncology Services, Radiation Oncology, Palliative Care/Home Care Teams, and Pain Units. The study intended to seek experts’ consensus and to define a set of recommendations for the management of BTcP. Results. It was generally agreed that, definition of BTcP implies that baseline pain should be controlled (84 %), although not necessarily with opioids (only 30 %); there must be exacerbations (98.9 %); the duration of each episode should last < 1 h (70 %); the intensity of pain ≥7 out of 10 (67.8 %); and the number of flares per day should not be less than four. All participants supported the use of the Davies algorithm for the diagnosis. The use of a ‘Patient Diary’ was highly recommended. The optimal treatment should have a rapid onset, a short-acting analgesic effect (1-2 h) and transmucosal nasal or oral administration. It was considered very important to develop protocols for the management of cancer pain. Conclusions. The present Delphi study identified a set of recommendations to define, assess and monitor BTcP (AU)

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Consensus and controversies in the definition, assessment, treatment and monitoring of BTcP: results of a Delphi study.

INTRODUCTION: There is no unanimous consensus on the clinical features to define breakthrough cancer pain (BTcP). The current project aimed to investigate the opinion of a panel of experts on cancer pain on how to define, diagnose, assess, treat and monitor BTcP. MATERIALS AND METHODS: A two-round Spanish multi-centre exploratory Delphi study was conducted with medical experts (n = 90) previously selected from Medical Oncology Services, Radiation Oncology, Palliative Care/Home Care Teams, and Pain Units. The study intended to seek experts' consensus and to define a set of recommendations for the management of BTcP. RESULTS: It was generally agreed that, definition of BTcP implies that baseline pain should be controlled (84 %), although not necessarily with opioids (only 30 %); there must be exacerbations (98.9 %); the duration of each episode should last <1 h (70 %); the intensity of pain ≥7 out of 10 (67.8 %); and the number of flares per day should not be less than four. All participants supported the use of the Davies algorithm for the diagnosis. The use of a 'Patient Diary' was highly recommended. The optimal treatment should have a rapid onset, a short-acting analgesic effect (1-2 h) and transmucosal nasal or oral administration. It was considered very important to develop protocols for the management of cancer pain. CONCLUSIONS: The present Delphi study identified a set of recommendations to define, assess and monitor BTcP.

Effect of a simple dose-escalation schedule on tramadol tolerability : assessment in the clinical setting.

OBJECTIVE: To assess the effect of a very simple dose-escalation schedule on tramadol tolerability in clinical practice. This schedule consists of starting treatment with sustained-release tramadol 50mg twice daily, and escalating the dose around 7 days later to 100mg twice daily. METHODS: Data from 1925 outpatients with non-malignant chronic pain were collected in this multicentre, prospective, comparative, non-randomised, open, observational study. RESULTS: A total of 1071 patients (55.6%) were included in the dose-escalation group (50mg group) and 854 patients (44.4%) in the control group (sustained-release tramadol 100mg twice daily; 100mg group). The proportion of patients who interrupted tramadol treatment due to the occurrence of adverse reactions was significantly lower in the 50mg group (5.6%) than in the 100mg group (12.6%) [p = 0.001]. In line with this, the proportion of patients who experienced at least one adverse reaction was significantly lower in the 50mg group (18.4%) than in the 100mg group (30.4%) [p = 0.001] and, interestingly, the two most frequently reported adverse reactions, nausea and dizziness, were found with a significantly lower frequency in the 50mg group (p < 0.001). Multivariate analysis showed that the risk of safety-related treatment cessations was 2.3 times higher in the 100mg group than in the 50mg group, and 2.2 times higher in females than in males. The two treatments were equally effective in reducing pain intensity (p = 0.121), measured as a reduction in pain score obtained by means of a visual analogue scale. CONCLUSION: The instauration of tramadol treatment, starting with sustained-release 50mg capsules twice daily and escalating the dose some days later to 100mg twice daily, was shown to be an effective and easy way to improve tramadol tolerability in clinical practice, whilst maintaining its analgesic efficacy.

Epidemiología, prevalencia y calidad de vida del dolor crónico no oncológico. Estudio ITACA / Epidemiology, prevalence and quality of life of non-malignant chronic pain. ITACA study

Objetivo: Describir y analizar las características epidemiológicas, clínicas y la calidad de vida de los pacientes con dolor crónico no oncológico no neuropático, incluidos en el estudio ITACA (Impacto del Tratamiento Analgésico sobre la Calidad de vida en Algias), en el que han participado 100 Unidades de Dolor de nuestro país. Material y métodos: El estudio ITACA es un estudio, prospectivo, observacional, multicéntrico de farmacoepidemiología, realizado en el primer semestre del año 2001. Los datos de la población estudiada han sido recogidos en la en la visita de inclusión de dicho estudio. Resultados: El estudio incluyó 907 pacientes, 66,03 por ciento mujeres y 33,97 por ciento hombres, la media de edad fue de 57,43 ñ 11,34 años. El 48 por ciento tenía una edad comprendida entre 55 y 70 años. El 92,56 por ciento viven en familia y el 74,44 por ciento en medio urbano. El 42,37 por ciento tenía sobrepeso y obesidad el 28,99 por ciento. La etiología del dolor crónico fue, por orden de frecuencia: lumbalgia (52,92 por ciento), seguida de osteroartritis (33,96 por ciento) y artrosis (30,65 por ciento). La antigüedad del proceso álgico fue de 5,32 ñ 6,31 años. Tenía algún tipo de limitación de la actividad física un 79 por ciento de la población. El 78,84 por ciento de los pacientes tomaba medicación concomitante para el tratamiento del dolor y el 69,6 por ciento seguía tratamiento con otros fármacos por procesos diferentes al dolor. Las patologías con más intensidad de dolor fueron la artrosis, osteoporosis con aplastamiento vertebral y osteoartritis, estando relacionado con el sexo femenino, peor calidad del sueño y con la edad mayor de 70 años. El dolor de menor intensidad estaba relacionado con el sexo masculino, edad menor de 55 años y padecer lumbalgia, dolor visceral e isquémico. Conclusiones: El resultado global obtenido de la población incluida en el estudio ITACA fue: la mayor parte de los pacientes pertenecen al sexo femenino, tienen una edad comprendida entre 55 y 70 años, padecen principalmente dolor crónico de origen lumbar degenerativo o inflamatorio, con una evolución media del mismo de 5,32 ñ 6,31 años, viven en familia, tienen sobrepeso y habitan en zonas urbanas. Existe una relación directa entre la intensidad del dolor y el grado de afectación de la calidad de vida de los pacientes. Se aprecia una mayor repercusión sobre el índice físico que el mental en la calidad de vida de la población estudiada. Los indicadores negativos de salud física son padecer artrosis y la intensidad de dolor, los positivos el dolor visceral y la escasa limitación de la actividad física. Las variables que influyen negativamente en la esfera mental de la calidad de vida están representadas por el sexo femenino, no tener estudios y tener una invalidez de la actividad (AU)

Efectividad, tolerabilidad y calidad de vida en el tratamiento del dolor crónico no oncológico, con tramadol de liberación controlada en dosis única diaria / Effectiveness, tolerability and quality of life in the management of chronic pain unrelated to cancer with sustained-release tramadol administered in a single daily dose

Objetivo: Evaluar la efectividad y tolerabilidad del tratamiento del dolor crónico no oncológico, con tramadol de liberación controlada y prolongada en dosis única diaria. Material y métodos: Estudio prospectivo, observacional, multicéntrico de farmacoepidemiología. En él participaron un total de 100 Unidades de Dolor de nuestro país. Se incluyeron pacientes con dolor crónico no oncológico que iniciaron tratamiento con tramadol de liberación controlada y prolongada. Para evaluar la efectividad del fármaco se registraron las características antropométricas, el tipo de dolor, su intensidad y su repercusión sobre el sueño y la calidad de vida. Se realizaron dos seguimientos: uno a la semana y otro al mes del inicio del tratamiento registrándose las variaciones en los indicadores de dolor: escala analógica visual y test de Lattinen, calidad de vida, la aparición de reacciones adversas y los cambios en el tratamiento. Resultados: Se estudiaron 907 pacientes, 66,03 por ciento mujeres y 33,97 por ciento hombres. El 52,92 por ciento de pacientes sufrían lumbalgia y el 33,96 por ciento osteoartritis. Se observó un descenso significativo en todos los indicadores de dolor desde la primera semana de tratamiento. La incidencia de efectos secundarios fue de un 16,8 por ciento, con una duración media de 6,3 ñ 4 días. Las náuseas y los vómitos fueron la reacción adversa con mayor incidencia (18,3 por ciento), seguida del estreñimiento y somnolencia (10,5 por ciento y 10,3 por ciento respectivamente).El mayor impacto de la respuesta analgésica de tramadol de liberación controlada y prolongada se reflejó en el índice del estado físico de la calidad de vida. El 93,22 por ciento de los pacientes cumplimentaron adecuadamente el tratamiento y el 66,38 por ciento se declararon satisfechos o muy satisfechos con el tratamiento al finalizar el estudio. Conclusiones: Tramadol de liberación controlada y prolongada se mostró altamente efectivo en la reducción del dolor desde la primera semana de tratamiento. La tolerabilidad fue buena, registrándose una reducida tasa de efectos adversos, leves. Las náuseas y vómitos fueron los que tuvieron mayor incidencia (AU)

Long-term brachial plexus anesthesia using a subcutaneous implantable injection system. Case report.

BACKGROUND AND OBJECTIVES: Continuous brachial plexus anesthesia with local anesthesia has been used since 1946 for prolonged surgical procedures, in postoperative pain relief, and in sympathetic nerve block. The benefit or effectiveness of this technique in the relief of sympathetically maintained pain has yet to be established. METHODS: The following case report describes the placement of an axillary catheter connected to a port for the self-administration of local anesthesia to provide brachial plexus anesthesia in a 43-year-old woman suffering from sympathetically maintained pain. RESULTS: The administration of local anesthesia through this injection system resulted in complete pain relief without motor impairment of the arm. The device functioned for 118 days, making physical therapy easier. An infection occurred at the entry site, requiring the removal of the port. CONCLUSIONS: Controlled studies need to be done to establish the safety and efficacy of this form of therapy.

Difficult management of pain following sacrococcygeal chordoma: 13 months of subarachnoid infusion.

We report on a patient suffering severe pain following a long-standing sacral chordoma in whom management of therapy and pain was extremely difficult. Because orally administered morphine was observed to be ineffective in the early stages of treatment, we tried to achieve pain relief by using epidural morphine. This was also unsatisfactory. Intrathecal infusion of morphine and bupivacaine through a catheter inserted at the L2-L3 level was also found to be ineffective; only a segment block was observed. A structural anomaly of the spine was suspected and confirmed by myelography, showing metastasis at L3. Pain relief improved when an infusion of morphine+bupivacaine was employed through a catheter placed at the L4-L5 level below the blockage. A major problem which continued throughout the course of the disease was the daily occurrence of episodes of unbearable sharp pain that required addition of midazolam to the local anesthetic/opioid subarachnoid infusion. The patient received this mixture through an intrathecal port during the last 13 months of life, a gradually increasing dose being necessary. Periods of analgesia were followed by occasional crises of intense sharp pain suggesting incomplete relief. No serious complications or meningitis occurred. This case emphasizes the difficulty in managing pain in this type of cancer.

[Influence of anesthetic technique in postoperative analgesia in thoracic surgery]. / Influencia de la técnica anestésica en la analgesia postoperatoria en cirugía torácica.

OBJECTIVE: To compare the intensity of postoperative pain after thoracotomy with 2 anesthetic techniques: 1) thoracic epidural block with bupivacaine administered before surgery (combined anesthesia with isoflurane) and 2) conventional balanced anesthesia with isoflurane and endovenous fentanyl. PATIENTS AND METHODS: Thirty patients scheduled for thoracotomy by lateral incision (T5-T6) were randomly divided into 2 groups of 15. Group A received 8 ml of 0.5% bupivacaine with adrenalin 1:200.000 30 min before start of surgery while group B received 8 ml saline solution through an epidural catheter inserted to T4-T8. Combined anesthesia (4 ml 0.5% bupivacaine through an epidural catheter 150 min after the first dose and isoflurane in 100% oxygen) was used in group A. Group B received balanced anesthesia with endovenous fentanyl 2.5 micrograms/kg and isoflurane in 100% oxygen. The difference in pain intensity during postoperative recovery was assessed by way of the following variables: number of boluses administered by epidural patient-controlled analgesia (bupivacaine 0.0625% and fentanyl 6 micrograms/ml); score on a visual analog scale of 10 at baseline and at 1, 3, 7, 11, 19 and 43 hours after surgery; and need for additional analgesia (diclofenac) during the 43 hours of study. Arterial gases were measured during the preoperative period and at 1, 3, 7, 19 and 43 hours after surgery. RESULTS: No significant differences in pain intensity measured on the visual analog scale, by the number of boluses per patients or by need for additional analgesia were found between the 2 groups. The total number of boluses administered and additional analgesic requirements were greater in the group receiving bupivacaine, although the difference was not significant (p = 0.095 and p = 0.056, respectively). Nor were there significant differences in pH and PaCO2 levels for the 2 groups. CONCLUSIONS: Analgesic efficacy after thoracotomy was similar for our 2 groups receiving either combined anesthesia (epidural bupivacaine at 0.5% and isoflurane) or balanced anesthesia with isoflurane and endovenous fentanyl.

[Comparison between fentanyl and a fentanyl-bupivacaine combination using epidural PCA for postoperative analgesia after thoracotomy]. / Comparación entre fentanilo y la asociación fentanilo-bupivacaína mediante PCA epidural en la analgesia postoperatoria de la toracotomía.

HYPOTHESIS: The association of opioids and local anesthetics for spinal analgesia appears to have a synergistic++ effect. OBJECTIVE: To compare the efficacy of fentanyl in comparison with combined fentanyl and bupivacaine at low concentrations in a thoracic epidural system of patient-controlled analgesia (PCA) following thoracotomy. PATIENTS AND METHODS: Twenty male patients scheduled for thoracotomy by postero-lateral (T5-T6) incision received analgesia after surgery through a thoracic (T4-T8) epidural catheter connected to a PCA pump (continuous infusion and boluses). They were randomly assigned to 2 groups as follows: group A (n = 10) received a baseline infusion of fentanyl 1 microgram/kg/h and bupivacaine 0.125% with boluses of 12.5 micrograms fentanyl and bupivacaine at 0.125%. The variables studied were: score on a visual analog scale (VAS) before treatment and at 12 and 24 h; the number of boluses administered through the PCA pump, forced vital capacity (FVC) and peak expiratory flow (PEF) before treatment and at 12 h. RESULTS: Analgesia was satisfactory in both groups, with no significant differences in VAS and number of boluses administered. Nor were there significant differences in lung function tests. One instance of respiratory depression was recorded in group A. CONCLUSIONS: The analgesic effect obtained with epidural fentanyl or fentanyl/bupivacaine is similar and adequate, and the association of fentanyl and bupivacaine can be considered safe.

Interpleural analgesia through a DuPen catheter for lung cancer pain.

BACKGROUND: Pain, one of the most frequent symptoms of lung cancer, is difficult to control at times, not only because of the many structures involved but also because of the paths through which the pain is conveyed. METHODS: When usual analgesic treatment did not alleviate pain after chemotherapy in a patient with lung adenocarcinoma, long-term interpleural analgesia was begun. A DuPen epidural catheter was inserted between the pleura parietalis and visceralis for the administration of bupivacaine in a bolus regimen every 6 hours. RESULTS: Thoracic pain thus was controlled until the patient died 130 days after placement. CONCLUSIONS: The long-term tunneled interpleural placement of DuPen catheters constitutes an alternative to systemic and spinal treatments for thoracic pain due to cancer.

Plasma bupivacaine levels after pleural block: the effect of epinephrine after unilateral or bilateral bupivacaine administration.

BACKGROUND AND OBJECTIVES: To determine the effect of adding epinephrine (5 micrograms/ml) to bupivacaine during continuous spinal infusion and the effect of the administration of the same total dose of bupivacaine, in a bilateral or unilateral way, on its consequent plasma levels. METHODS: Sixteen cholecystectomized patients were studied prospectively. In ten patients with midline incision, bilateral pleural infusion (half total unilateral dose in each hemithorax) was administered, and in six patients with subcostal incision, unilateral pleural infusion. The unilateral group received a loading dose of 20 ml 0.375% bupivacaine immediately followed by an infusion at a rate of 6 ml/hour. Three patients randomly received epinephrine (5 micrograms/ml) added to bupivacaine, whereas the other three remaining patients did not receive it. The bilateral group received 10 ml 0.375% bupivacaine followed by an infusion at a rate of 3 ml/hour in each hemithorax. Five patients randomly received epinephrine; five others did not. The plasma levels of bupivacaine were determined at 5, 15, 30, and 60 minutes and at 6 and 18 hours. RESULTS: Plasma levels of bupivacaine were significantly lower (p less than 0.05) during the whole study in patients receiving epinephrine. For the same total dose, there were no statistical differences in the plasma levels of bupivacaine between unilateral and bilateral pleural groups. CONCLUSIONS: The addition of epinephrine (5 micrograms/ml) to a continuous pleural infusion of bupivacaine diminishes the plasma levels of the local anesthetic. For the same total dose of bupivacaine, there are no differences in the plasma levels obtained between unilateral and bilateral administration.