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BMC Anesthesiology
Published in: BMC Anesthesiology 1/2015

Open Access 01-12-2015 | Research article

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

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

Published in: BMC Anesthesiology | Issue 1/2015

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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
Literature
1.
Fletcher D, Fermanian C, Mardaye A, Aegerter P. A patient-based national survey on postoperative pain management in France reveals significant achievements and persistent challenges. Pain. 2008;137:441–51.CrossRefPubMed
2.
Morrison RS, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, et al. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003;103:303–11.CrossRefPubMed
3.
Gerbershagen HJ, Aduckathil S, van Wijck AJM, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013;118:934–44.CrossRefPubMed
4.
5.
Philip BK, Reese PR, Burch SP. The economic impact of opioids on postoperative pain management. J Clin Anesth. 2002;14:354–64.CrossRefPubMed
6.
White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005;101:S5–22.CrossRefPubMed
7.
Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005;102:1249–60.CrossRefPubMed
8.
Gehling M, Arndt C, Eberhart LHJ, Koch T, Krüger T, Wulf H. Postoperative analgesia with parecoxib, acetaminophen, and the combination of both: a randomized, double-blind, placebo-controlled trial in patients undergoing thyroid surgery. Br J Anaesth. 2010;104:761–7.CrossRefPubMed
9.
Kyriakidis AV, Perysinakis I, Alexandris I, Athanasiou K, Papadopoulos C, Mpesikos I. Parecoxib sodium in the treatment of postoperative pain after Lichtenstein tension-free mesh inguinal hernia repair. Hernia. 2010;15:59–64.CrossRefPubMed
10.
Barton SF, Langeland FF, Snabes MC, LeComte D, Kuss ME, Dhadda SS, et al. Efficacy and safety of intravenous parecoxib sodium in relieving acute postoperative pain following gynecologic laparotomy surgery. Anesthesiology. 2002;97:306–14.CrossRefPubMed
11.
Malan TP, Marsh G, Hakki SI, Grossman E, Traylor L, Hubbard RC. Parecoxib sodium, a parenteral cyclooxygenase 2 selective inhibitor, improves morphine analgesia and is opioid-sparing following total hip arthroplasty. Anesthesiology. 2003;98:950–6.CrossRefPubMed
12.
Hubbard RC, Naumann TM, Traylor L, Dhadda S. Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia. Br J Anaesth. 2003;90:166–72.CrossRefPubMed
13.
Riest G, Peters J, Weiss M, Dreyer S, Klassen PD, Stegen B, et al. Preventive effects of perioperative parecoxib on post-discectomy pain. Br J Anaesth. 2007;100:256–62.CrossRefPubMed
14.
Ott E, Nussmeier NA, Duke PC, Feneck RO, Alston RP, Snabes MC, et al. Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2003;125:1481–92.CrossRefPubMed
15.
Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med. 2005;352:1081–91.CrossRefPubMed
16.
Solomon SD, McMurray JJV, Pfeffer MA, Wittes J, Fowler R, Finn P, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005;352:1071–80.CrossRefPubMed
17.
Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005;352:1092–102.CrossRefPubMed
18.
White PF, Kehlet H, Liu S. Perioperative analgesia: what do we still know? Anesth Analg. 2009;108:1364–7.CrossRefPubMed
19.
Marret E, Elia N, Dahl JB, McQuay HJ, Møiniche S, Moore RA, et al. Susceptibility to fraud in systematic reviews: lessons from the Reuben case. Anesthesiology. 2009;111:1279–89.CrossRefPubMed
20.
Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study. Circulation. 2002;105:310–5.CrossRefPubMed
21.
Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;23:129–38.PubMed
22.
Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004;99:699–709.CrossRefPubMed
23.
Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, et al. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010;105:511–8.CrossRefPubMed
24.
Stahl DL, Groeben H, Kroepfl D, Gautam S, Eikermann M. Development and validation of a novel tool to estimate peri-operative blood loss*. Anaesthesia. 2012;67:479–86.CrossRefPubMed
25.
Phillips DM. JCAHO pain management standards are unveiled. Jt Comm Perspect JAMA. 2000;284:428–9.
26.
Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002;3:159–80.CrossRefPubMed
27.
Gray A. Predicting postoperative analgesia outcomes: NNT league tables or procedure-specific evidence? Br J Anaesth. 2005;94:710–4.CrossRefPubMed
28.
Elia N, Lysakowski C, Tramèr MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005;103:1296–304.CrossRefPubMed
29.
Rømsing J, Møiniche S, Mathiesen O, Dahl JB. Reduction of opioid-related adverse events using opioid-sparing analgesia with COX-2 inhibitors lacks documentation: A systematic review. Acta Anaesthesiol Scand. 2005;49:133–42.CrossRefPubMed
30.
Jensen MP, Mendoza T, Hanna DB, Chen C, Cleeland CS. The analgesic effects that underlie patient satisfaction with treatment. Pain. 2004;110:480–7.CrossRefPubMed
31.
Gan TJ, Joshi GP, Zhao SZ, Hanna DB, Cheung RY, Chen C. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004;48:1194–207.CrossRefPubMed
32.
Langford RM, Joshi GP, Gan TJ, Mattera MS, Chen W-H, Revicki DA, et al. Reduction in opioid-related adverse events and improvement in function with parecoxib followed by valdecoxib treatment after Non-cardiac surgery. Clin Drug Investig. 2009;29:577–90.CrossRefPubMed
33.
Maund E, McDaid C, Rice S, Wright K, Jenkins B, Woolacott N. Paracetamol and selective and non-selective non-steroidal anti-inflammatory drugs for the reduction in morphine-related side-effects after major surgery: a systematic review. Br J Anaesth. 2011;106:292–7.CrossRefPubMed
34.
Munsterhjelm E. Influence on platelet aggregation of i.v. parecoxib and acetaminophen in healthy volunteers. Br J Anaesth. 2006;97:226–31.CrossRefPubMed
35.
Scharbert G, Gebhardt K, Sow Z, Duris M, Deusch E, Kozek-Langenecker S. Point-of-care platelet function tests: detection of platelet inhibition induced by nonopioid analgesic drugs. Blood Coagul Fibrinolysis. 2007;18:775–80.CrossRefPubMed
36.
Ibrahim A, Park S, Feldman J, Karim A, Kharasch ED. Effects of parecoxib, a parenteral COX-2-specific inhibitor, on the pharmacokinetics and pharmacodynamics of propofol. Anesthesiology. 2002;96:88–95.CrossRefPubMed
37.
38.
Cheetham TC, Levy G, Niu F, Bixler F. Gastrointestinal safety of nonsteroidal antiinflammatory drugs and selective cyclooxygenase-2 inhibitors in patients on warfarin. Ann Pharmacother. 2009;43:1765–73.CrossRefPubMed
39.
Undas A, Brummel-Ziedins KE, Mann KG. Antithrombotic properties of aspirin and resistance to aspirin: beyond strictly antiplatelet actions. Blood. 2007;109:2285–92.CrossRefPubMedPubMedCentral
40.
Nielsen JD, Gram J, Holm-Nielsen A, Fabrin K, Jespersen J. Post-operative blood loss after transurethral prostatectomy is dependent on in situ fibrinolysis. BJU Int. 1997;80:889–93.CrossRef
41.
Laird A, Fowler S, Good DW, Stewart GD, Srinivasan V, Cahill D, Brewster SF, McNeill SA. Contemporary practice and technique-related outcomes for radical prostatectomy in the UK: a report of national outcomes. BJU INt 2014 [Epub ahead of print].
42.
Webster TM, Herrell SD, Chang SS, Cookson MS, Baumgartner RG, Anderson LW, et al. Robotic assisted laparoscopic radical prostatectomy versus retropubic radical prostatectomy: a prospective assessment of postoperative pain. J Urol. 2005;174:912–4.CrossRefPubMed
Metadata
Title
Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial
Authors
Daniel Dirkmann
Harald Groeben
Hassan Farhan
David L Stahl
Matthias Eikermann
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Anesthesiology / Issue 1/2015
Electronic ISSN: 1471-2253
DOI
https://doi.org/10.1186/s12871-015-0015-y

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