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临床试验/NCT03847792
NCT03847792已完成不适用

Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery

Mansoura University2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2019年3月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Duration of postoperative analgesia

研究概览

简要总结

However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.

详细描述

Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.

Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status (ASA) I or II

排除标准

  • Contraindication to spinal anesthesia.
  • Allergy to the study drugs.
  • Refusal of the patients.

研究组 & 干预措施

Group DB/Dexamethasone-Bupivacaine

Active Comparator

Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine

干预措施: Group DB/Dexamethasone-Bupivacaine (Drug)

Group FB /Fentanyl-Bupivacaine

Active Comparator

Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine

干预措施: Group FB /Fentanyl-Bupivacaine (Drug)

Group PB/Placebo-Bupivacaine

Placebo Comparator

Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine

干预措施: Group PB/Placebo-Bupivacaine (Drug)

结局指标

主要结局

Duration of postoperative analgesia

时间窗: for 24 hour after surgery

Time to the first request of pethidine in minutes within the first 24 hours postoperatively

次要结局

  • Total analgesic requirement(for 24 hour after surgery)
  • Mean arterial blood pressure(At 1,2,4,6,8,12,18 and 24 hours postoperatively.)
  • Patients' satisfaction(for 24 hour after surgery)
  • Heart rate(At 1,2,4,6,8,12,18 and 24 hours postoperatively.)
  • Pain score(measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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