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
Highlights
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
In order to overcome the limitations of every single score, we developed and validated the OBAS by using pain scores, opioid consumption, as well as the m-BPI-sf, and opioid-related symptom distress scale (OR-SDS), previously [23]
One patient had to be excluded for protocol violation, another due to an adverse event, and three patients had to be excluded because of withdrawal of consent
Summary
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. Despite the growing evidence that there are procedure specific differences in postoperative pain, guidelines are generalized for most surgical procedures [3] and opioids are being used as the mainstay of analgesia [4]. Their use is associated with well known side effects, which. Long-term use of two other COX-2 inhibitors (namely celecoxib and rofecoxib) has been associated with an increased cardiovascular risk in large trials that sought to assess the preventive effects of these drugs on colorectal adenoma development [16,17]. There are data suggesting that COX-2 inhibitors may increase perioperative blood loss in non cardiac surgery [11]
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