compare the efficacy and safety of norspan to tramadol/acetaminophen with prolonged postoperative pain (passion)

Conditions: Pain

Summary: the purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.


Eligibility criteria:
inclusion criteria: * korean men and women aged 20 years or more * presence of pain associated with a spinal disease and lumbar fusion at 1-2 spinal segments (1-2 level lumbar fusion surgery) * moderate to severe pain of the nrs pain score ≥ 4 at visit 1 (14\~90 days after surgery, baseline) (amended 21nov2013) * consent to participate in the study and voluntary signature on the informed consent form exclusion criteria: * women of childbearing potential, except for the following cases: * a partner who is vasectomized or otherwise surgically sterile. * use of 2 contraception methods. two methods include the combination of double-barrier contraception or barrier contraception and hormone contraception, and appropriate barrier methods are as follows: diaphragm (female contraceptive device), condom, intrauterine (copper or hormone), sponge or spermicide. hormonal contraceptives include all commercially available products containing estrogen and/or progesterone. * pregnant or breastfeeding women. pregnant woman is defined as a woman after fertilization to late pregnancy with a positive result from the urine pregnancy test. * history of hypersensitivity to buprenorphine, tramadol, apap or excipients, and celecoxib * medical history of asthma, acute rhinitis, nasal polyp, vascular edema urticaria or allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs(nsaids, cox-2) * hypersensitivity or intolerance to domperidone * risk of gastrointestinal irritation such as gastrointestinal bleeding, mechanical ileus or perforation * genetic problem such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * severely impaired respiratory function or respiratory depression * current use of monoamine oxidase(mao) inhibitors or the medication history within 2 weeks prior to study participation * convulsive disorder, head injury, shock, decreased level of consciousness of uncertain origin, intracranial lesion or increased intracranial pressure or severe hepatic impairment * biliary tract disorder * presence or suspected drug abuse history * medical history of opioid or drug dependence * current use of other cns inhibitors or muscle relaxants that may result in dyspnea, hypotension, severe sedation or coma when used with the investigational product, opioid analgesics * use of strong opioids, buprenorphine or tramadol/apap within 1 week prior to study participation (however, study participation is allowed for prn prescription of pca and strong opioids) * any condition representing a contraindication of application of buprenorphine, tramadol/apap or celecoxib * major pain not attributable to a spinal disease * anticancer therapy that may affect pain assessment * clinically significant cardiovascular or renal dysfunction * postoperative complications * symptoms of acute pain after lumbar fusion or characteristic analgesic features showing rapidly changing needs for analgesics * current use of other investigational product at enrollment or within 30 days after administration of other investigational product