Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.
Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.
Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.
详细描述
Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate.
Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient.
Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.
Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo.
At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery.
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
- Double (Participant, 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
- 否
入选标准
- •Patients undergoing a lumbar slipped disc surgery
- •Aged 18 to 85 years.
- •ASA score I-III
- •Having given their consent.
- •Affiliated with a social security scheme
排除标准
- •Patients who must be operated urgently.
- •Patients previously operated for lumbar spinal surgery.
- •Expected duration of surgery more than 3 hours.
- •Severe renal impairment defined by a creatinine clearance less than or equal to 30 mL/min.
- •Taking long-term strong opiates .
- •Taking long-term corticosteroids or within 48 hours before surgery.
- •Taking pregabalin or gabapentin within 48 hours before surgery.
- •Drug addiction.
- •Patients with cognitive impairment (judged by the investigator) that may interfere with:
- •informed consent, the collection of endpoints, the use of auto-controlled analgesia.
- •Pregnant or nursing women.
- •Refusal of the protocol.
- •Minor or major protected patients.
- •Allergy or other cons-indication to the molecules used in the protocol.
研究组 & 干预措施
Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products
干预措施: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) (Drug)
Lactose (150mg), NaC1 0.9% (50ml)
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products
干预措施: Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg) (Drug)
结局指标
主要结局
Pain
时间窗: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Pain evaluated by ENS during the first mobilization at the edge of the bed
时间窗: at J0+1 day
次要结局
- pain(at H0+12h)
- pain(at H0+24h)
- Pain(during the first mobilization with standing up at J1)
- Postoperative Nausea and Vomiting(at H0+24h)
- Sedation(at J0 at the arrival in the operating room)
- Sedation(at J0 at the end of SSPI)
- Sedation(at H0+24 h)
- pain(at H0+1h)
- pain(at H0+1h30)
- pain(at H0+2h)
- pain(at H0+6h)
- Quality of the standing up (evaluated by Likert scale)(at J0+1day)
- Sedation(at H0+48h)
- pain(at H0+48h)
- Consumption of morphine(between H0+2h and H0+24h)
- Pain at rest(at J0+180 days)
- Existence of lightheadedness(at H0, between H0 and H0+48H)
- Existence of urinary retention(at H0, between H0 and H0+48H)
- Pain(at H0+0h30)
- Patient satisfaction (evaluated by Likert scale)(at J0+1 day)
- assessment of neuropathic component DN4 scale(at J0+180 days)
- Postoperative Nausea and Vomiting(at H0+48h)
- Existence of pruritus(at H0, between H0 and H0+48H)
- statement of analgesic treatment(at J0+180 days)
- Pain during mobilization(at J0+180 days)
- Existence of visual disturbances(at H0, between H0 and H0+48H)