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

Daniel Dirkmann, Harald Groeben, Hassan Farhan, David L Stahl, Matthias Eikermann, Daniel Dirkmann, Harald Groeben, Hassan Farhan, David L Stahl, Matthias Eikermann

Abstract

Background: This 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.

Methods: 105 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.

Results: In 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).

Conclusions: Following 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 registration: ClinicalTrials.gov Identifier: NCT00346268.

Keywords: Analgesics non-opioids; Analgesics opioids; Morphine; Pain; Parecoxib; Postoperative pain.

Figures

Figure 1
Figure 1
Patient flow chart.
Figure 2
Figure 2
Cumulative amount of morphine used at 48 hours following skin closure. Mean (symbols) and standard deviation (error bars). Morphine consumption was significantly (24%) less in the parecoxib group vs. placebo.
Figure 3
Figure 3
Scoring system variables of analgesic efficacy at 48 hours following skin closure. OBAS (A), OR-SDS score (B), m-BPI-sf pain perception score (C), and m-BPI-sf pain interference score (D). Box-plots of quartiles (boxes), median (line within box), minimum, and maximum (error bars). All measurements of analgesic efficacy were significantly less in the parecoxib group vs. placebo.
Figure 4
Figure 4
Decrease in hemoglobin concentration (Hb) measured as: Hb [g⋅dL−1] preoperatively–Hb [g⋅dL−1] at 48 hours following skin closure + RBCU during 48 hours; where RBCU during 48 hours is the number of red blood cell units (RBCU) transfused after open prostatectomy until 48 h after skin closure. Box-plots of quartiles (boxes), median (line within box), minimum, and maximum (error bars). Decrease in Hb was significantly higher in the parecoxib group vs. placebo at 24 hours.

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