Protocol Title: A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Analgesic Efficacy And Safety of IV ParacetamolVersus Placebo in subjects with postoperative pain after Total Hip Arthroplasty

Bristol-Myers Squibb S0 个研究点目标入组 140 人开始时间: 2006年1月17日最近更新: 2022年4月19日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bristol-Myers Squibb S
入组人数: 140

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Subject is willing to participate in the study and sign the informed consent.
•2) All subjects must have the ability to read and understand the study procedures and the use of the pain scales, must be able to operate a PCA device and to
•communicate meaningfully with the study observer and staff.
•3) In-patients with ASA risk class I, II or III according to the American Society of
•Anaesthesiologist (Appendix 1).
•4) Subjects undergoing total hip arthroplasty and prepared for PCA during the
•anesthetic consultation.
•5) Surgery conducted under standardized spinal anesthesia and presenting a
•Modified Bromage Score equal to 2 (almost complete block), after arrival in the
•6) Body mass index (BMI) greater than or equal to 19 and less than or equal to 35
•7) Men or women (not nursing and not pregnant) at least 18 years of age but no
•greater than 80 years old.
•Women of childbearing potential (WOCBP) must be using an adequate method of
•contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
•8) Subject free of any contra-indication to the study drugs, or excipients, the rescue
•medication and to the standardized anesthesia protocol.
•9) Subjects free of other painful physical conditions which, in the opinion of the
•investigator, may confound quantifying postoperative pain resulting from hip
•arthroplasty.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1) WOCBP who are unwilling or unable to use an acceptable method to avoid
•pregnancy for the entire study period and for up to 4 weeks after the study.
•2) WOCBP using a prohibited contraceptive method
•3) Women who are pregnant or breastfeeding.
•4) Women with a positive pregnancy test on enrollment or prior to study drug
•administration.
•5) Subject for whom the spinal anesthesia was converted to general anesthesia
•during the procedure.
•6) Subject who needs simultaneously any additional surgery procedures unrelated to
•hip arthroplasty during the same session.
•7) Subject scheduled for early reintervention or reinstrumentation, i.e. within 60
•days of the initial procedure or less.
•8) Subject with abnormally high perioperative blood loss at risk of hypovolemia
•during the postoperative period.
•9) Subject with known or suspected history of alcohol or drug abuse.
•10) Subject with psychiatric disease or medical conditions which in the opinion of the
•investigator may invalidate subject ability to communicate with the investigator or
•to comply with the study procedures.
•11) Subject having a history of complete non-response to either paracetamol,
•NSAID’s or tramadol when seeking pain relief; subjects having previously
•required more than usual doses of analgesics for comparable surgical procedures.
•12) Subject with any known significant medical disease(s) or condition(s) that in the
•investigator´s judgement could compromise the subject´s ability to communicate
•with the study staff or contraindicate study participation.
•13) Impaired liver function (transaminases > 3 x upper limit of normal range).
•14) Advanced renal dysfunction (creatinine > 2.0 mg/dL or 170 µmol/L) or subject at risk for renal failure due to volume depletion.
•15) Subject with coagulation alterations.
•16) Any additional laboratory abnormality which, in the investigator´s opinion would
•contraindicate study participation.
•17) Respiratory insufficiency or severe cardiac insufficiency not stabilized by therapy.
•18) Chronic malnutrition.
•19) Subject with raised intracranial pressure or convulsions.
•20) Known hypersensitivity or contraindications to study drugs or related compounds, rescue medication, standardized anaesthesia or to inactive ingredients of the study medication.
•21) Subject who has taken NSAIDs within 8 hours (48 h for long acting NSAIDs)
•before administration of the study medications, any analgesic drug within the 12 hours (48 h for long acting drugs) prior to administration of the study medications
•or any medication that, in the opinion of the Investigator, would be expected to
•confound the analgesic responses.
•22) Subject who is taking any concomitant treatments (i.e. sedatives, hypnotics,
•anxiolytics, anti-depressant drugs, tranquilizers) which could potentially confound
•the quantification of analgesia.
•23) Subject treated with MAO inhibitors or whose treatment with these has been
•stopped less than 10 days prior to surgery; subject treated with corticosteroids or
•whose treatment with these has been stopped less than 7 days prior surgery.
•24) Subject treated with agents known to affect microsomal enzymes (such as
•rifampicin, barbiturates, izoniazid, anticonvulsants, zidovudine, and tricyclic
•antidepressants), and/or agents which could affect the analgesic response (such as
•neuroleptic agents, clonidine and anti-psychotic agents) except as indicated in the
•standardized anesthesia protocol.
•25) Subject treated with anticoagulants (except for heparin 5000 UI).
•26) Prisoners o

研究者

发起方

Bristol-Myers Squibb S

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