Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total Dose of Opioids consumed in the intraoperative period
研究概览
简要总结
Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain.
Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation.
The ideal pain management procedures are based on the multimodal analgesia model, based in turn on the combination of products and / or techniques to improve the quality of analgesia, reduce the side effects linked to the use of opioids, reduce responses to surgical stress, reduce postoperative recovery and allow rapid rehabilitation of the patient.
The aim of our study is to investigate whether clonidine combined with levobupivacaine in the pudendal block reduce the total consumption of opioids in proctological 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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signature of informed consent
排除标准
- •Refusal to participate ;
- •Allergy to either local anaesthetics or clonidine;
- •Local infectious pathologies (e.g. acute ano-perineal suppuration)
- •Pregnancy
- •Breastfeeding
- •Severe bradyarrhythmia due to sinus node disease or second and third degree atrioventricular block
- •Severe depressive condition
- •Severe coronary artery disease
- •Raynaud's disease
- •Heart failure
- •Obliterating thromboangiitis
- •Spinal anesthesia
研究组 & 干预措施
Group Clonidine
Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side.
干预措施: Clonidine (Drug)
Group Clonidine
Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side.
干预措施: Levobupivacaine (Drug)
Control
Group Control will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine per side; 0.5 ml of 0.9% NaCl will be added to each syringe to homogenise the volume in order to remain blind.
干预措施: Levobupivacaine (Drug)
Control
Group Control will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine per side; 0.5 ml of 0.9% NaCl will be added to each syringe to homogenise the volume in order to remain blind.
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Total Dose of Opioids consumed in the intraoperative period
时间窗: up to 24 hours post-surgery
Total consumption of sufentanyl during the intraoperative period (in micrograms). The administration of sufentanyl depends on the change of physiological parameters (augmentation of 20% of blood pressure and/or cardiac frequency).
次要结局
- Patient satisfaction(up to 24 hours post-surgery)
- Total consumption of tramadol in post-operative period(up to 24 hours post-surgery)
- Total consumption of paracetamol in post-operative period(up to 24 hours post-surgery)
- Total consumption of diclofenac in post-operative period(up to 24 hours post-surgery)
- Post-operative Pain as assessed by Visual Analog Scale(up to 24 hours post-surgery)
- Total Dose of piritramide consumed in the recovery room(up to 24 hours post-surgery)
- Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)(during the hospitalization in Post Anesthesia Care Unit (PACU))
- Time before First Use of Rescue Analgesic(up to 24 hours post-surgery)
- Total Dose of tramadol consumed in the recovery room(up to 24 hours post-surgery)
- Need for tramadol administration per patient during the first 24 hours(up to 24 hours post-surgery)