Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial

被引:6
作者
de Hoogd, Sjoerd [1 ]
Ahlers, Sabine J. G. M. [1 ]
van Dongen, Eric P. A. [2 ]
Tibboel, Dick [3 ,4 ]
Dahan, Albert [5 ]
Knibbe, Catherijne A. J. [1 ,3 ,4 ,6 ]
机构
[1] St Antonius Hosp, Dept Clin Pharm, NL-3435 CM Nieuwegein, Netherlands
[2] St Antonius Hosp, Dept Anesthesiol & Intens Care, NL-3435 CM Nieuwegein, Netherlands
[3] Sophia Childrens Univ Hosp, Erasmus MC, NL-3015 CN Rotterdam, Netherlands
[4] Sophia Childrens Univ Hosp, Erasmus MC, Dept Pediat Surg, NL-3015 CN Rotterdam, Netherlands
[5] Leiden Univ, Med Ctr, Dept Anesthesiol, NL-2333 ZA Leiden, Netherlands
[6] Leiden Univ, Leiden Acad Ctr Drug Res, Div Pharmacol, Leiden, Netherlands
来源
TRIALS | 2014年 / 15卷
关键词
Chronic pain; Sternotomy; Remifentanil; Fentanyl; Postoperative pain; OPIOID-INDUCED HYPERALGESIA; POST-STERNOTOMY PAIN; D-ASPARTATE RECEPTOR; SHORT-TERM INFUSION; RISK-FACTORS; POSTINFUSION HYPERALGESIA; POSTOPERATIVE PAIN; INDUCED ANALGESIA; PREVALENCE; HUMANS;
D O I
10.1186/1745-6215-15-466
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: Chronic thoracic pain after cardiac surgery is prevalent (11 to 56%) and may affect patients' physical and mental health status. Despite its favorable pharmacokinetic and pharmacodynamic properties, high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and increased requirements for analgesics. Recently, an association between remifentanil use and the incidence of chronic thoracic pain in the long term was also reported. Our objective is to investigate the influence of the intraoperative remifentanil on chronic postoperative pain in a prospective randomized controlled trial. Methods/design: In this prospective, randomized, single-blind clinical trial, all patients (N = 126) between 18 and 85 years undergoing cardiac surgery via sternotomy receive a continuous infusion of propofol together with intermittent intravenous fentanyl at predetermined times perioperatively. Patients are randomized to receive either an additional continuous infusion of remifentanil (0.15 mu g(-1)kgIBW(-1) min(-1)) or additional fentanyl (200 to 500 mu g) as needed during surgery. The primary end point is the prevalence of chronic thoracic pain 12 months after surgery. Secondary end points include acute postoperative pain; postoperative analgesic use; chronic thoracic pain 3 and 6 months after surgery; quality of life (SF-12) at 3, 6 and 12 months after surgery; work productivity; and use of health care. In addition, thermal detection and pain thresholds are measured preoperatively, 3 days after surgery and 12 months after surgery using quantitative sensory testing (QST). Finally, the influence of several genetic variances on the different outcomes will be measured. Discussion: Chronic thoracic pain is prevalent after cardiac surgery, and research is needed to minimize the risk of chronic persistent postoperative pain, which is an invalidating, long-term complication of surgery. The objective of this trial is to determine the influence of perioperative remifentanil on long-term pain outcomes for cardiac patients in a prospective randomized trial. The results may be used to optimize perioperative analgesia techniques and, thereby, improve quality of life after cardiac surgery.
引用
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页数:6
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