Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids.

BACKGROUND: Guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic cancer pain, but individual responses can vary. This study compared the analgesic efficacy, changes of therapy and safety profile over time of four strong opioids given for cancer pain. PATIENT AND METHODS: In this four-arm multicenter, randomized, comparative, of superiority, phase IV trial, oncological patients with moderate to severe pain requiring WHO step III opioids were randomly assigned to receive oral morphine or oxycodone or transdermal fentanyl or buprenorphine for 28 days. At each visit, pain intensity, modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy end point was the proportion of nonresponders, meaning patients with worse or unchanged average pain intensity (API) between the first and last visit, measured on a 0-10 numerical rating scale. (NCT01809106). RESULTS: Forty-four centers participated in the trial and recruited 520 patients. Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs. Nonresponders ranged from 11.5% (morphine) to 14.4% (buprenorphine). Appreciable changes were made in the treatment schedules over time. Each group required increases in the daily dose, from 32.7% (morphine) to 121.2% (transdermal fentanyl). Patients requiring adjuvant analgesics ranged from 68.9% (morphine) to 81.6% (oxycodone), switches varied from 22.1% (morphine) to 12% (oxycodone), discontinuation of treatment from 27% ( morphine) to 14.5% (fentanyl). ADRs were similar except for effects on the nervous system, which significantly prevailed with morphine. CONCLUSION: The main findings were the similarity in pain control, response rates and main adverse reactions among opioids. Changes in therapy schedules were notable over time. A considerable proportion of patients were nonresponders or poor responders. CLINICAL TRIAL REGISTRATION: NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).

Use of oxycodone controlled-release immediately after NSAIDs: a new approach to obtain good pain control.

INTRODUCTION: Opioids are recommended as appropriate therapy for the treatment of cancer pain and chronic non-malignant pain. Oxycodone is an alternative agent to its parent compound, morphine, and is available in a controlled-release (CR) formulation that allows convenient twice-daily dosing. The aim of this study was to evaluate the efficacy and tolerability of oxycodone CR as first-line therapy in patients with chronic cancer or non-cancer pain that was not relieved by non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: This was a prospective, open-label, multicentre trial carried out in 8 pain and oncology centres in Italy. Patients (n = 309) with NSAID-refractory chronic cancer (55.7%), noncancer (39.4%) or mixed (4.9%) pain (rating of 4-10 on a numerical rating scale [NRS] from 0-10) were enrolled. Patients were treated with oral oxycodone CR twice daily for at least 28 days. Dosage was individualized for each patient and up-titrated over the first week of treatment. The primary endpoint was reduction in NRS score for pain. Secondary endpoints were tolerability, quality of life and patient assessment of treatment efficacy. RESULTS: A significant decrease (57%) in pain intensity was recorded during the first week of therapy (decrease in NRS score from 7.85 +/- 1.4 to 3.35 +/- 1.8; p < 0.00001). Overall, there was a 72.3% reduction in NRS pain score from baseline at the end of the study. Quality of life significantly (p < 0.005) improved during oxycodone therapy, and 91% of patients rated treatment as "effective" or "very effective". Five patients stopped oxycodone CR treatment because of adverse events, and one stopped treatment because of dysphagia. CONCLUSIONS: The results of this study demonstrate the efficacy and tolerability of oxycodone CR in patients with moderate-to-severe pain of a variety of aetiologies and confirm the feasibility and effectiveness of moving directly from step I to step III on the WHO analgesic treatment ladder.

Acupuncture treatment of dysmenorrhea resistant to conventional medical treatment.

We evaluated the effect of acupuncture on NSAID resistant dysmenorrhea related pain [measured according to Visual Analogue Scale (VAS)] in 15 consecutive patients. Pain was measured at baseline (T1), mid treatment (T2), end of treatment (T3) and 3 (T4) and 6 months (T5) after the end of treatment. Substantial reduction of pain and NSAID assumption was observed in 13 of 15 patients (87%). Pain intensity was significantly reduced with respect to baseline (average VAS = 8.5), by 64, 72, 60 or 53% at T2, T3, T4 or T5. Greater reduction of pain was observed for primary as compared with secondary dysmenorrhea. Average pain duration at baseline (2.6 days) was significantly reduced by 62, 69, 54 or 54% at T2, T3, T4 or T5. Average NSAID use was significantly reduced by 63, 74, 58 or 58% at T2, T3, T4 or T5, respectively, and ceased totally in 7 patients, still asymptomatic 6 months after treatment. Our findings suggest that acupuncture may be indicated to treat dysmenorrhea related pain, in particular in those subjects in whom NSAID or oral contraceptives are contraindicated or refused.

Tracheal rupture after tracheal intubation: effectiveness of conservative treatment.

A tracheal rupture is a rare complication of tracheal intubation. Risk factors include advanced age, COBP and corticosteroid therapy. The direct causes of the rupture are difficult tracheal intubation, particularly with a stylet inside the tube and overdistension of the cuff of the tracheal tube. The case of a 73-year-old woman with a tracheal rupture after an uncomplicated operation of a vaginal hysterectomy and bilateral adenexectomy is reported. The procedure of orotracheal intubation presented no difficulties. However, after 5 h the patient was presenting unexpected symptoms such as dyspnea and subcutaneous emphysema. After an inconclusive chest X-ray and chest TC, the diagnosis was made by emergency fiberendoscopy. We adopted a conservative treatment, consisting of a tracheal intubation and chest drain, which resulted in a full recovery after 5 days of mechanical ventilation. The causes that could have provoked a tracheal laceration in our patient and the suggested therapies with preference for conservative treatment, are discussed. We recommend a tracheal tube cuff monitoring during surgery, to prevent fatal overinflation of the cuff, which is permeable to nitrous oxide.

The role of the pain therapist in the approach to chronic headache.

Chronic daily headache (CDH) represents, for the anesthesiologists, a big match in the management of a pain which is simultaneously central and periferic, of a pain wich is psychical and disabiliting. This is a pain conducting the patient to overuse analgesic medicaments even making worse "allodynia" and the organic integrity. That's why a multidisciplinary approach to this kind of chronic benign pathology permits to improve prognosis and quality of life.

[Cataract surgery: regional anesthesia or monitored anesthesia care?]. / Chirurgia della cataratta: anestesia loco-regionale o assistenza anestesiologica monitorizzata?

BACKGROUND: Retrospective study in patients undergoing cataract surgery by facoemulsification in order to evaluate the incidence of regional peribulbar anaesthesia compared with MAC (Monitored Anesthesia Care). METHODS: Between January 1999 and December 2000, 1902 patients were studied. Peribulbar anaesthesia was performed by using a double or single inferior-lateral injection with a mixture of Lidocaine 2% and Bupivacaine 0.5% or, as a single agent, of Ropivacaine 0.75%. Jaluronydase 10 UI/ml was added to either agents. RESULTS: Only in 8% of patients intravenous drugs were added during surgery to correct bradycardia in 3%, hypertension 3% and for sedation in 2%. CONCLUSIONS: Regional anesthesia represents the most suitable anesthesia technique in patients undergoing cataract surgery by facoemulsification. Only in 8% of patients MAC was suitable, due to excessive anxiety or cardiovascular imbalance. Compared to other anesthesia techniques, regional anaesthesia is significantly safer. The utility of preoperative tests in reducing the morbidity associated with surgery, is also discussed.