Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial

Abstract

BackgroundThis multi-centre, prospective, randomized, double-blind, placebo-controlled study was designed to test the hypotheses that parecoxib improves patients’ postoperative analgesia without increasing surgical blood loss following radical open prostatectomy.Methods105 patients (64 ± 7 years old) were randomized to receive either parecoxib or placebo with concurrent morphine patient controlled analgesia. Cumulative opioid consumption (primary objective) and the overall benefit of analgesia score (OBAS), the modified brief pain inventory short form (m-BPI-sf), the opioid-related symptom distress scale (OR-SDS), and perioperative blood loss (secondary objectives) were assessed.ResultsIn each group 48 patients received the study medication for 48 hours postoperatively. Parecoxib significantly reduced cumulative opioid consumption by 24% (43 ± 24.1 mg versus 57 ± 28 mg, mean ± SD, p=0.02), translating into improved benefit of analgesia (OBAS: 2(0/4) versus 3(1/5.25), p=0.01), pain severity (m-BPI-sf: 1(1/2) versus 2(2/3), p < 0.01) and pain interference (m-BPI-sf: 1(0/1) versus 1(1/3), p=0.001), as well as reduced opioid-related side effects (OR-SDS score: 0.3(0.075/0.51) versus 0.4(0.2/0.83), p=0.03). Blood loss was significantly higher at 24 hours following surgery in the parecoxib group (4.3 g⋅dL−1 (3.6/4.9) versus (3.2 g⋅dL−1 (2.4/4.95), p=0.02).ConclusionsFollowing major abdominal surgery, parecoxib significantly improves patients’ perceived analgesia. Parecoxib may however increase perioperative blood loss. Further trials are needed to evaluate the effects of selective cyclooxygenase-2 inhibitors on blood loss.Trial registrationClinicalTrials.gov Identifier: NCT00346268

Effect of Parecoxib as an Adjunct to Patient-Controlled Epidural Analgesia after Abdominal Hysterectomy: A Multicenter, Randomized, Placebo-Controlled Trial

“…Our data are consistent with these findings because the perioperative administration of 40 mg parecoxib had no significant effects on coagulation function or blood loss, which is consistent with the findings that parecoxib exerts a minimal effect on serum thromboxane and platelet function [ 13 , 41 , 42 ]. However, a significant decrease in hemoglobin concentration during the first 24 hours following skin closure associated with parecoxib (4.3 g⋅dL − 1 (3.6/4.9) vs. 3.2 g⋅dL −1 (2.4/5.0)) has been recently reported, while lack of statistical significance in intraoperative blood loss and the total blood loss at 48 hours postoperatively between both groups [ 43 ]. An increased incidence of postoperative anemia but lack of statistical significance associated with parecoxib (14.1% vs. 10%) has also been previously reported [ 44 ].…”

Perioperative bleeding and non-steroidal anti-inflammatory drugs

“…However, further understanding of these mechanistic variations and their influence on clinical outcomes is essential and therefore remains a focus in current research. Dirkmann et al [ 37 ] conducted a multicenter, double-blind RCT, assigning radical prostatectomy patients to receive an initial 40 mg IV dose of the selective COX-2 inhibitor parecoxib or placebo and subsequent doses of 20 mg parecoxib (parecoxib group) or placebo (placebo group) every 12 hour until 48 hour post-surgery, with availability of patient controlled analgesia (PCA) morphine. This study reported reduced opioid consumption and an improved benefit of analgesia (OBAS score, taking into account pain intensity, opioid-related AEs, and patient satisfaction) in patients receiving parecoxib, but also significantly greater blood loss (decrease in serum hemoglobin: 4.3 g/dL versus 3.2 g/dL for placebo; P = .02), suggesting potential bleeding risks associated with this COX-2-selective drug.…”

Optimal pain management for radical prostatectomy surgery: what is the evidence?

“…Non-selective NSAIDs can increase the potential risk of bleeding [ 53 ] in contrast to COX-2 selective inhibitors. However, a recent randomized, placebo-controlled, double-blind trial in patients undergoing open prostatectomy reported that while parecoxib reduced opioid use and opioid-related side effects, blood loss at 24 h after surgery was significantly higher in comparison to the placebo group, corresponding to a 1 g/dL difference in hemoglobin [ 54 ].…”