Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block. A Prospective Randomized Study in Ambulatory Patients Undergoing Upper Limb Bone Surgery Under Single Shot Axillary Plexus Block
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence of severe postoperative rebound pain
研究概览
简要总结
Risk factors and Prevention of severe Pain upon cessation of a peripheral nerve block. A prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.
详细描述
Pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time.
Severe post-operative pain is a risk factor for chronic pain. Use of a well-known molecule, regularly used in anesthesiology. Prospective double-blind study on 120 patients. Pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients.
The anti-hyperalgesic properties of ketamine could be a benefit against this effect.
No studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release.
This may improve patients' post-operative comfort. The patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10mL saline or 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of 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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The local pharmacy department is in charge of unmasking the drug.
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
- •any ambulatory upper limb bone surgery carried out under axillary PNB
排除标准
- •Refusal to participate
- •Contraindication to the use of ketamine
- •Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
- •Pregnant woman
- •Diabetic patient
- •Vascular patient
- •Cognitive disorders
- •Inability to answer perioperative questionnaires (language problem)
研究组 & 干预措施
Study drug
0.3 mg/kg intravenous ketamine diluted into 10mL saline after the realization of peripheral nerve block (PNB), before tourniquet set up and beginning of surgery
干预措施: Ketalar, 5 mg/mL Injectable Solution (Drug)
Placebo
10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery
干预措施: Placebo (Other)
结局指标
主要结局
incidence of severe postoperative rebound pain
时间窗: from surgery to 30 days post operation
Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more.
次要结局
- To measure the impact of ketamine on the level of "rebound pain" in patients with central sensitivity using the Numerical Rating Scale(from surgery to 30 days postoperatively)