Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery - an Exploratory Placebo-controlled Clinical Study to Investigate the Analgesic Properties of the Combination of Diclofenac and Orphenadrine Versus Diclofenac Alone.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg
研究概览
简要总结
The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.
详细描述
The clinical study is planned as a double-blind, randomised, treatment-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion.
Patients who meet the inclusion and exclusion criteria will be enrolled to the clinical study and receive an enrolment number. The enrolment number will be a 4-digit number where the leftmost position will be zero ("0"). Enrolled patients will receive enrolment numbers starting at 0001, 0002, and so forth.
Only patients who were successfully randomized after surgery will continue the study protocol. All other patients will be regarded as screening failures. Successfully randomized patients will receive two infusions over 60 - 90 minutes with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device and will be allowed on demand analgetics as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low.
Anaesthesia will be induced with propofol (1.0-2.5 mg/kg), remifentanil (1 mcg/kg over minimum of 30s) and rocuronium (0.6mg/kg) and subsequently maintained with remifentail (0.25 - 1 mcg/kg/min), and sevoflurane. During skin suture, 7.5 mg piritramid will be administered. No nitrous oxide will be administered.
No other narcotics, analgesics, or sedatives than those described herein will be allowed. In case the surgical procedure mandates the use of additional and/or other narcotics, analgesics, or sedatives it shall be up to the investigator to decide on further treatment. However, in such case the patient will not be randomized and will be regarded as screening failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective cruciate ligament surgery
- •Confirmed patient suitability for planned surgery
- •Legally valid signed written informed consent provided
- •Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding
- •Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
- •No known intolerabilities or hypersensitivities to any part of the IMP / control medication
- •No reoperation/revision within 6 months after the initial surgery
- •Absence of history of abuse of analgesics or other drug
- •No analgesics within 48 hours prior to surgery (surgery-related medication excluded)
- •No current / recent (within 4 weeks prior to enrolment) experimental treatment
- •No current / recent (within 4 weeks prior to enrolment) participation in another clinical study
- •No foreseeable difficulties with regard to protocol compliance
- •No known hypersensibility against the active ingredients diclofenac, orphenadrine, remifentanil, propofol, rocuronium, and hydromorphone
- •No known hypersensibility against the other ingredients of the investigational medicinal product
- •Absence of congestive heart failure classes 2 or higher according to the NYHA classification
- •Absence of ischemic heart disease
- •Absence of peripheral arterial occlusive disease
- •Absence of cerebro-vascular disease
- •Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, type-2 diabetes, moderate smoking defined as consumation of 11 cigarettes or more per day)
- •exclusion criteria
- •Major complications during surgery possibly leading to problems in the handling of the PCA or subsequently with the experimental treatment
- •Intolerable adverse events or any serious adverse event
- •Severe violation of the clinical study protocol
- •Withdrawal of patient informed consent
排除标准
- 未提供
研究组 & 干预措施
Neodolpasse
In the Neodolpasse® arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
Neodolpasse® Infusion Solution combines 75 mg (250 mL) of the NSAID diclofenac with 30 mg of the muscle-relaxant orphenadrine.
干预措施: Neodolpasse (Drug)
Diclofenac
In the Diclofenac arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
The Infusion solution contains 75 mg (250 mL) of the NSAID diclofenac.
干预措施: Diclofenac (Drug)
Placebo
In the Placebo arm patients receive two physiologic saline infusion (250 mL) over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg
时间窗: within 24 hours
amount of pca analgetic administered
次要结局
- VAS-Scale: Pain relief will be tracked during the infusion periods and until 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS).(after 24 hours)
研究者
Oliver Kimberger
Deputy Head of Department of Anesthesiology, General Intensive Care and Pain Medicine
Medical University of Vienna