A randomized, double-blind, placebo-controlled study of preemptively administered intravenous parecoxib: effect on anxiety levels and procedural pain during epidural catheter placement for surgical operations or for chronic pain therapy

Abstract

Background: The effect of parecoxib, when used perioperatively or during interventional techniques, is well demonstrated in the literature. Little is known about its effects on anxiety levels before the analgesic technique application. The aim of this prospective, randomized, double-blind, placebo-controlled, clinical study is to investigate whether parecoxib, preemptively administrated, has an effect on anxiety levels reported prior to an epidural puncture, and if it influences the reported pain of the interventional technique itself.

Material and methods: The study protocol involved 110 patients, scheduled for epidural catheter placement for chronic pain therapy--Group I, as well as 112 patients scheduled for orthopedic operations under epidural anesthesia--Group II. Patients in each group were randomly allocated into two subgroups in relation to parecoxib/placebo administration before epidural catheter placement: Group Ia, parecoxib 40 mg i.v. (n = 54), Group Ib, placebo (n = 56), Group IIa, parecoxib 40 mg i.v. (n = 57), Group IIb, placebo (n = 55). Patients were given a self-administered inventory to measure the anxiety level of the presurgical/preprocedural state (State-Trait Spielberger Anxiety Inventory) and anxiety levels were recorded 1 hour before epidural puncture, 20 minutes postdosing, and 1 hour after epidural catheter placement. Anxiety levels were also measured and recorded using visual analog scale (VAS). One hour after epidural puncture, reported procedural pain was recorded (VAS). One hour and 6 hours postepidural, patients' satisfaction was also recorded, on a 4-point scale.

Results: All four subgroups were similar regarding demographic, operative/procedural data, and coexisting diseases. Preprocedural anxiety levels were significantly decreased with parecoxib administration in comparison with placebo in both groups (P < 0.05). Reported VAS regarding pain from epidural puncture was lower in Groups IA and Ib. Patients' satisfaction was greater with parecoxib in comparison with placebo.

Conclusion: The levels of anxiety have been investigated in several medical procedures and early, in the study of pain. The higher the expectation of pain and the anxiety are, the higher the intensity of the pain. Parecoxib seems to exert positive influence on pain and anxiety levels of interventional procedure. Further studies are needed to elucidate the actual mechanisms that are involved.