Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- numeric rating scale (NRS)
研究概览
简要总结
Infraclavicular nerve catheter for postoperative analgesia will be included in the 70 adult patients undergoing upper extremity surgery included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the number of pushing the button, the amount of bolus dose given, the total dose given in the patient controlled anesthesia device, the need for additional analgesia and the amount, pain scores, complications will be recorded for three days postoperatively. Records will be compared statistically.
详细描述
Ethics committee approval was received on 10 December 2019, numbered 19/398. The study was planned to include 70 adult patients undergoing upper extremity surgery at Gulhane Training and Research Hospital between 10 December 2019 and February 2020. Continue infraclavicular nerve catheter for postoperative analgesia will be included in the patients included in the study. These patients will be randomized to the catheter tip configuration as CEMP(closed-ended multiport catheter) group and OESP(open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients who have placed an infraclavicular catheter and used the catheter successfully for three days postoperatively, the number of pushing the button, the amount of bolus dose given and the total dose given in the patient controlled anesthesia device,the amounts of need for additional analgesia and pain scores(Numeric rating Scale), complications will be recorded. Records will be compared statistically.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Score I-III
- •upper extremity surgery
排除标准
- •emergency surgery,
- •secondary surgery,
- •chronic pain treatment
- •pregnancy,
- •any contraindication to peripheral nerve blockade,
- •pre-existing peripheral nerve neuropathy,
- •allergy to local anesthetics (study medications),
- •ASA score ≥ 4,
- •neurologic or neuromuscular disease,
- •psychiatric disease,
- •renal failure,
- •hepatic failure,
- •NSAID contraindication,
- •inability to use a patient controlled analgesia (PCA) device,
- •infection at the injection site
- •withdrawal of consent.
研究组 & 干预措施
CEMP (closed-ended multiport catheter) group
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
干预措施: CEMP (closed-ended multiport catheter) group (Procedure)
CEMP (closed-ended multiport catheter) group
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
干预措施: Patient-controlled analgesia (Procedure)
OESP (open-ended single port catheter) group
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
干预措施: OESP (open-ended single port catheter) group (Procedure)
OESP (open-ended single port catheter) group
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
干预措施: Patient-controlled analgesia (Procedure)
结局指标
主要结局
numeric rating scale (NRS)
时间窗: three days postoperatively
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
data from patient-controlled analgesia (PCA) device
时间窗: three days postoperatively
The number of PCA button presses
Data from patient-controlled analgesia (PCA) device
时间窗: three days postoperatively
Total amount (ml) of local anesthetic (0.125% bupivacaine) delivered to patient recorded by patient controlled analgesia device.
complications related to opioids
时间窗: three days postoperatively
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,
the requirement for additional analgesia
时间窗: three days postoperatively
Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered intravenously as rescue analgesia to patients with an NRS score above 3 and recorded.
次要结局
未报告次要终点
研究者
Mehmet Burak Eşkin
Assistant Professor
Gulhane School of Medicine