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临床试验/NCT04715152
NCT04715152已完成2 期

Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
72
试验地点
1
主要终点
The pain free time after surgery

研究概览

简要总结

Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.

详细描述

Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours.

Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. In addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. Systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects.

The saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. Although adductor canal block (ACB) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (FNB).

Intra-articular (IA) local anesthetic agents have been used either alone or in combination with other agent. However, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug.

Dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. It blocks the nociceptive impulse transmission along the myelinated C fibers. Dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old

排除标准

  • Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
  • History of cardiovascular, cerebrovascular, and respiratory diseases
  • Preexisting neuropathies
  • Chronic pain syndrome
  • Opioid dependence
  • Patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction
  • Pregnancy
  • Not willingness to participate.

研究组 & 干预措施

ACB group

Active Comparator

Patients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.

干预措施: ACB group (Drug)

IA group

Placebo Comparator

Patients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.

干预措施: IA group (Drug)

结局指标

主要结局

The pain free time after surgery

时间窗: 1440 minutes (24 hours) after surgery

assessed in minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seham Mohamed Moeen Ibrahim

Principal Investigator

Assiut University

研究点 (1)

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