TY - JOUR
T1 - Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy
T2 - A multicentre randomized trial
AU - Dirkmann, Daniel
AU - Groeben, Harald
AU - Farhan, Hassan
AU - Stahl, David L.
AU - Eikermann, Matthias
N1 - Funding Information:
This investigator initiated, multi-centric, prospective, double-blind, placebo-controlled study was conducted in compliance with the ‘Declaration of Helsinki’ and according to ‘Good Clinical Practice’ guidelines, at three German hospitals. Patients were recruited between December 2006 and September 2010, when the study was prematurely terminated due to slow recruitment as a result of increasing use of robot assisted surgery at all investigational centers. The study was funded by Pfizer, Germany. Pfizer was involved in the generation of the study design. However, Pfizer did not influence the interpretation and the discussion of results. The study was registered at www. clinicaltrials.gov (Identifier: NCT00346268). The study was reviewed and approved by the ethics committee of the University Duisburg-Essen (Ethik-Komission der Universität Duisburg Essen, Robert-Koch-Straße 9–11, 45147 Essen, Germany, protocol number: A3481066,
Publisher Copyright:
© 2015 Dirkmann et al.
PY - 2015/3/9
Y1 - 2015/3/9
N2 - 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.
AB - 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.
KW - Analgesics non-opioids
KW - Analgesics opioids
KW - Morphine
KW - Pain
KW - Parecoxib
KW - Postoperative pain
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U2 - 10.1186/s12871-015-0015-y
DO - 10.1186/s12871-015-0015-y
M3 - Article
C2 - 25767411
AN - SCOPUS:84928709197
SN - 1471-2253
VL - 15
JO - BMC Anesthesiology
JF - BMC Anesthesiology
IS - 1
M1 - 31
ER -