Evaluation of Intraoperative Dexamethasone Efficacy to Prevent Rebound Pain Phenomenon According to Individual Patient Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Impact of baseline levels of Lipocortin 1 and cortisol on the efficacy of DEXA on the occurrence of RP
研究概览
简要总结
The study will evaluate pain and recovery after a single injection axillary plexus block combined with an intravenous dose of 0.1 mg/kg dexamethasone in ambulatory patients undergoing upper extremity bone surgery. The investigators will try to identify the risk factors involved in a decrease in the efficacy of dexamethaxone for the prevention of RP.
The hypotheses are that :
- The interindividual variability may modulate the preventive effect on "rebound pain" after axillary block, of pre-incisional administration of an anti-inflammatory dose of dexamethasone (0.1 mg/kg max 10 mg).
- Patients with increased preoperative anxiety or underlying catastrophizing will experience more postoperative pain as the axillary PNB dissipates.
- Elevated preoperative salivary lipocortin 1 and cortisol levels result in a lesser preventive effect of dexamethasone on the development of rebound pain.
详细描述
The use of a peripheral nerve block (PNB) through local anesthetics administered may exacerbate the acute inflammatory process induced by the surgical trauma, which may cause rebound pain once the block is lifted, also called "Rebound pain" (RP).
The administration of a dose of Dexamethasone (DEXA) IV as an adjuvant, to optimize the effectiveness of PNB by increasing the duration of PNB , is already a validated practice in anesthesia. In addition the well known analgesic effects of DEXA on postoperative pain (dose> 0.1 mg/kg) seem to contribute to the decrease in RP occurring in the first 24 hours after surgery . These protective properties of DEXA with respect to this phenomenon of hyperalgesia could be explained, among other things, by its modulatory actions on the inflammatory reaction and inhibitory actions on cyclooxygenase as well as its effect on the production of specific mediators such as cytokines.
However, even if DEXA can reduce the onset of RP in some patients, its efficacy seems to be variable and inconsistent between individuals, as suggested by the results of a retrospective observational study .
It can thus be assumed that some individuals are less sensitive to the preventive administration of DEXA and this for different reasons that it would be interesting to better understand .
Objectives:The primary objective will be to identify factors predisposing to variations in the efficacy of DEXA on the occurrence of RP by characterizing the basal stress state of the patient, the level of anxiety and pre-existing catastrophism, as well as the basal thresholds of Lipocortin 1 and cortisol and the basal inflammatory degree (CR high sensitivity) The secondary objective will be to evaluate the interindividual variability of the preventive efficacy of pre-incisional systemic administration of an anti-inflammatory dose of DEXA (0.1 mg/kg, 10 mg maximum) on the occurrence of RP during axillary block removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 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
- •Patient aged between 18 and 75 yrs old
排除标准
- •Refusal to participate
- •Contraindication to the use of Dexamethasone
- •Patient with corticoids intake for various reasons
- •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)
结局指标
主要结局
Impact of baseline levels of Lipocortin 1 and cortisol on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Baseline levels of Lipocortin 1 and cortisol (salivary assays in nmol/L) and measurements of blood mediators of inflammation, C-Réactive Proteine (CRP) value (in milligrams/liter) and NLR value (neutrophil to lymphocyte ratio) .
Impact of preoperative anxiety levels on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Preoperative anxiety levels (APAIS scale). The score can range from 6 ("no anxiety") to 30 ("very anxious").
Impact of BMI on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Body mass index BMI (combination of weight measurement in Kilograms and height in meters to obtain BMI in kg/m\^2),
Impact of sexe on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Sexe (male ,female),
Impact of preoperative levels of pre-existing catastrophizin on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Preoperative levels of pre-existing catastrophizing .(13 items scored from 0 to 4)
Impact of preoperative levels of central sensitization on the efficacy of DEXA on the occurrence of RP
时间窗: Through study completion, an average of 1 year
- Preoperative levels of central sensitization index (CSI) (9 questions)
次要结局
- Inter-individual variability of preventive efficacy of DEXA(Through study completion, an average of 1 year)