mobiflex and Ovarian-Neoplasms

This study compared postoperative analgesic dispensation and measures relating to haemostasis following intravenous administration, in a randomized double-blinded manner, of either placebo or tenoxicam 20 mg to 30 women presenting for major gynaecological oncology surgery under a standardized, combined epidural/general anaesthetic technique. Pharmacokinetic disposition of tenoxicam in this patient cohort was also described. There was no objective or subjective alteration in haemostatic function or increase in blood loss, nor any deviation from the normal range of values. Postoperative analgesia during the first 48 hours was delivered to achieve a VAS endpoint of less than five on leg-raising, by a combination of a nurse-controlled low-dose background epidural infusion and patient-administered epidural bolus. Greater VAS variability was observed during the first four postoperative hours (P = 0.08). The tenoxicam group self-administered significantly fewer epidural bolus doses to maintain satisfactory analgesia compared with the placebo group during the first 24 hours (P = 0.004) and 48 hours (P = 0.01) postoperatively. Similar differences between the groups in the total dose of the epidural bupivacaine/fentanyl mixture delivered were described (4 h: P = 0.148; 24 h: P = 0.033; 48 h: P = 0.001) (Figure 2). Despite surgery, transfusion and the use of a renal protective fluid administration strategy, tenoxicam disposition was not greatly different from that widely described for healthy volunteers. There were no significant side-effects and no adverse events attributable to tenoxicam. In this small study we have shown that tenoxicam administered preoperatively reduced the epidural analgesic requirements during the first 48 hours following major gynaecological surgery. There was no clinical or pathological evidence of haematological impairment following a single i.v. administration of tenoxicam 20 mg.

Topics: Aged; Anesthesia, Epidural; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Half-Life; Humans; Infusions, Intravenous; Metabolic Clearance Rate; Middle Aged; Ovarian Neoplasms; Pain Measurement; Pain, Postoperative; Piroxicam; Preoperative Care; Uterine Cervical Neoplasms

Thirty women presenting for major gynaecological oncology surgery under a standardized, combined epidural/general anaesthetic technique received either placebo or tenoxicam 20 mg intravenously, in a randomized double-blinded manner prior to surgery. Plasma and urinary electrolytes, creatinine, prostaglandins PgE2 and PgF1 alpha, and thromboxane (TxB2) were collected 12 hours preoperatively and then for four days postoperatively. There were no significant differences in any of the measured parameters between the groups, at any of the measurement times. Mean (SD) creatinine clearance at baseline, 24 h and 48 h was 100.4 (29.7) and 86.9 (27.5), 128.1 (45.9) and 115.0 (40.3), 137.5 (50.7) and 121.6 (38.6) in the placebo and tenoxicam groups respectively (P = 0.28). Both groups required similar amounts of intraoperative ephedrine and intravenous fluids to maintain blood pressure. The minimal changes in plasma and renal parameters reflect predictable responses to major surgery and rehydration rather than any response to cyclooxygenase inhibition. This may underscore the importance of maintenance of blood pressure during the course of surgery and postoperative care, and perhaps the usefulness of a fluid loading regimen to preserve renal function during surgery. The predicted attenuation of renal prostaglandin-mediated protective mechanisms and enhancement of the catecholamine-mediated renal vasoconstriction by the use of a single 20 mg dose of tenoxicam in this study were not seen. Modulation of renal concentrating mechanisms or excretion of sodium and potassium by tenoxicam was not apparent and a large increase in study size would be required to detect a significant difference in these parameters as a consequence of the drug, over and above any changes in response to surgery and epidural anaesthesia.

Topics: Aged; Analgesia, Epidural; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Electrolytes; Female; Glomerular Filtration Rate; Humans; Kidney; Middle Aged; Ovarian Neoplasms; Piroxicam; Preoperative Care; Prostaglandins; Uterine Cervical Neoplasms