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Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.

ABSTRACT: Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy.The study is a 2 x 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a pre- and postoperative setting. The total observation period is 6 months. According to a power analysis, 120 patients scheduled for abdominal or thoracic surgery will randomly be allocated to either the preemptive or the postoperative treatment group. These two groups are each divided into two arms. Preemptive group patients receive etoricoxib prior to surgery and either etoricoxib again or placebo postoperatively. Postoperative group patients receive placebo prior to surgery and either placebo again or etoricoxib after surgery (2 x 2 factorial study design). The Main Outcome Measure is the cumulative use of morphine within the first 48 hours after surgery (measured by patient controlled analgesia PCA). Secondary outcome parameters include a broad range of tests including sensoric perception and genetic polymorphisms.The results of this study will provide information on the analgesic effectiveness of etoricoxib in preemptive analgesia and will give hints on possible preventive effects of persistent pain.NCT00716833.

SUBMITTER: Fleckenstein J

PROVIDER: S-EPMC2890651 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.

Fleckenstein Johannes J Kramer Sybille S Offenbächer Martin M Schober Gabriel G Plischke Herbert H Siebeck Matthias M Mussack Thomas T Hatz Rudolf R Lehmeyer Lukas L Lang Philip M PM Heindl Bernhard B Conzen Peter P Irnich Dominik D

Trials 20100527

<h4>Background and objective</h4>Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy.<h4>Design and methods</h4>The study is a 2 x 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a ...[more]

PMID: 20504378

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Project description:BackgroundThe effectiveness of preemptive analgesia (PA) for relieving postoperative pain and reducing the side effects of analgesics following video-assisted thoracoscopic surgery (VATS) has not yet been determined. This study intends to test the clinical application value of PA in the perioperative period of VATS.MethodsFrom January 2018 to August 2018, we divided patients who underwent VATS in our hospital into a trial group (PA group) and a control group (traditional analgesia group, TA group). The PA group received a PA program, and the TA group was administered a conventional postoperative analgesia scheme. We compared the two groups according to the intensity of postoperative pain using the numeric rating scale (NRS), the incidence rate of analgesic drug-related adverse reactions, and the severity of stress-induced inflammation.ResultsOne hundred five cases from the PA group, and 80 cases from the TA group were included in the analysis. There were no significant differences between the two groups in baseline characteristics (P>0.05). The PA group had a lower incidence rate of side effects from the analgesics compared to the TA group, and there was a statistical difference at 48 and 72 hours after surgery (P<0.05). The PA group had a slightly lower score than the TA group for postoperative resting pain. However, this difference was not statistically significant (P>0.05). The motion pain NRS score of the PA group was lower than the TA group, and although there were no significant differences at 4, 24, and 48 hours (P>0.05), there was a statistically significant difference at 72 hours (P<0.05). In the subset of patients with motion pain NRS ≥3 points, the PA group was marginally higher than the TA group at 4 hours (P>0.05) but was lower than the TA group at 24, 48, and 72 hours, with a statistically significant difference at 24 and 72 hours (P<0.05). There were no statistically significant differences in perioperative stress indexes between the two groups (P>0.05).ConclusionsPA can relieve postoperative pain following VATS and reduce the incidence rate of analgesic drug-related adverse effects.

Project description:IntroductionThis study aims to determine whether paravertebral block (PVB) provides better postoperative analgesia, lower incidence of complications and faster recovery compared with local anaesthetic wound infiltration for school-aged children undergoing cardiac surgery with cardiopulmonary bypass via thoracotomy.Method and analysisThis is a single-centre, randomised controlled trial. We will enrol 100 children aged 6-14 years with atrial or ventricular septal defects scheduled for thoracotomy cardiac surgery with cardiopulmonary bypass. The patients will be randomly assigned to the PVB group and the control group in a ratio of 1:1. After the surgery, we will conduct unilateral PVB with ropivacaine for patients in the PVB group, and local anaesthetic wound infiltration for patients in the control group. We will use the double-dummy design to ensure blinding. The patients will not be administered analgesics after returning to the PICU(paediatric intensive care unit). Their bedside nurse will monitor their pain condition. When the Faces Pain Scale-Revised (FPS-R) Pain Score is ≥4, sufentanil infusion will be started. The primary outcome will be total opioid consumption within 24 hours after surgery. Secondary outcomes will be (1) FPS-R Scores at 6 hours, 12 hours, 18 hours and 24 hours after surgery; (2) The rate of opioid treatment for remedial analgesia; (3) The first time of FPS-R Score is ≥4 postoperatively. Exploratory outcomes will be: (1) Length of postoperative mechanical ventilation, ICU stay and hospital stay; (2) The rate of postoperative nausea and vomiting and respiratory depression 24 hours after surgery.Ethics and disseminationThis study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2023-2135) and PUMC. Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.Trial registration numberChinese Clinical Trial Registry (ChiCTR2400081773) Clinical Trial（NCT06312904）.

Project description:BackgroundPostoperative atrial fibrillation (POAF) is an ordinary complication of surgery, particularly cardiac surgery. It significantly increases in-hospital mortality and costs. This study aimed to establish a nomogram prediction model for POAF in patients undergoing laparotomy. The model is expected to identify individuals at a high risk of POAF before surgery in clinical practice.MethodsA retrospective observational case-control study involving 230 adult patients (60 patients with POAF, 120 patients in the control group, and 50 patients in the validation group) who underwent laparotomy was retrieved from two hospitals. Independent risk variables for POAF were investigated using logistic regression and the least absolute shrinkage and selection operator (LASSO) regression analysis. Subsequently, a nomogram model for POAF was constructed by multivariate logistic regression equations. The prediction model was internally validated by bootstrap method and externally validated with the validation group data. To assess the discriminative ability of the nomogram model, a receiver operating characteristic (ROC) curve was generated and a calibration curve was employed to assess the concentricity between the model's probability curve and the ideal curve. Subsequently, decision curve analysis (DCA) was performed to assess the clinical effectiveness of the model.ResultsC-reactive protein (CRP), lymphocyte-to-monocyte ratio(LMR), blood urea nitrogen (BUN), and Macruz index were independent risk variables for POAF in patients who underwent laparotomy. A user-friendly and efficient prediction nomogram was visualized using R software. This nomogram exhibited strong discrimination, as evidenced by an area under the ROC curve (AUC) of 0.90 (95% CI 0.8509-0.9488) for the training set, 0.86 (95% CI 0.7142-1) for the test set, and 0.9792 (95% CI 0.9293-1) for the validation group data. The C-index of the bootstrap nomogram model was 0.8998. Furthermore, DCA revealed that this model displayed excellent fit and calibration, as well as positive net benefits.ConclusionsA nomogram prediction model was constructed for POAF in patients who underwent abdominal surgery. The nomogram prediction model is expected to identify individuals at high risk of POAF in clinical practice for prophylactic therapeutic intervention prior to surgery.

Dataset Information

Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.

Publications

Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.

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