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临床试验/NCT07279727
NCT07279727尚未招募1 期

Ultrasound-Guided Infraclvicular Block Using Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Upper Limb Orthopedic Surgery: A Prospective, Randomized, Double-Blind Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Our primary outcome of this study will be: Duration of Analgesia.

研究概览

简要总结

this study is designed to evaluate and compare the efficacy of dexmedetomidine and nalbuphine as adjuvants to 0.5% bupivacaine in ultrasound-guided infraclavicular brachial plexus block for patients undergoing elective upper limb orthopedic surgeries on the duration of analgesia.

详细描述

Regional anesthesia is an integral component of modern anesthetic practice. It provides high-quality surgical anesthesia and superior postoperative analgesia while avoiding airway manipulation, minimizing systemic opioid use, and facilitating early ambulation and discharge .

Compared with general anesthesia, regional techniques reduce postoperative pain scores, nausea, and opioid requirements, leading to faster recovery and higher patient satisfaction. They are especially valuable in orthopedic upper-limb surgeries where prolonged postoperative analgesia is desired.

For upper limb procedures, various brachial plexus approaches-interscalene, supraclavicular, infraclavicular, and axillary-are utilized depending on the surgical site. Ultrasound guidance has greatly improved the safety and success rates of these blocks by allowing direct visualization of the nerves, needle, and spread of local anesthetic (LA).

The infraclavicular approach targets the cords of the brachial plexus surrounding the axillary artery in the infraclavicular fossa. It provides dense anesthesia and analgesia for surgeries of the elbow, forearm, and hand. Advantages over the supraclavicular or axillary approaches include reliable blockade of the musculocutaneous, median, ulnar, and radial nerves with a single injection, Lower risk of pneumothorax or phrenic nerve palsy and better catheter stability for continuous analgesia .

Despite these benefits, the main limitation is the finite duration of analgesia when using local anesthetics alone. Adjuvants have been explored to extend block duration and enhance quality without increasing toxicity. Commonly used agents include opioids, clonidine, dexmedetomidine, magnesium sulfate, dexamethasone, and others.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

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

  • Adults aged 18-65 years ASA I-II (American Society of Anesthesiologists physical status classification) Scheduled for elective upper limb orthopedic surgeries Able to provide informed consent to participate in the study

排除标准

  • Refusal to participate in the study Pregnancy Allergy to any study drug(s) Neurological disease (e.g., neuropathies, central nervous system disorders) Coagulopathy or active bleeding disorders Severe systemic diseases (e.g., uncontrolled cardiovascular, renal, or liver disease) Opioid abuse or history of substance use disorder

研究组 & 干预措施

nalbuphine group

Active Comparator

• Patients in group N (Nalbuphine group) will receive 29 mL of 0.5% bupivacaine + 1 mL (containing 10 mg nalbuphine)

干预措施: Nalbuphine (Drug)

Dexmedetomidine group

Active Comparator

• Patients in group D (Dexmedetomidine group) will receive 29 mL of 0.5% bupivacaine + 1mL (containing 75 µg dexmedetomidine

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Our primary outcome of this study will be: Duration of Analgesia.

时间窗: till 24 hour postoperative

Definition: The time interval (in minutes) between the completion of the infraclavicular block injection and the first request for rescue analgesia (VAS ≥ 3). Scale: Visual Analog Scale (VAS) Scale Title: Visual Analog Scale for Pain (VAS) Minimum Value: 0 (no pain) Maximum Value: 10 (worst possible pain) Interpretation: Higher VAS scores indicate worse pain, and a score of ≥ 3 indicates the need for rescue analgesia.

次要结局

  • Onset time of sensory and motor block(till 20 minute after the block)
  • Duration of sensory and motor block(20 minute after the block)
  • Time to first rescue analgesic request(till 24 hour postoperative)
  • Heart rate (HR)(till 24 hour postoperative)
  • Mean arterial blood pressure (MAP)(24 hour postoperative)

研究者

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

Mo'men mostafa youssef

Lecturer of Anesthesia and icu

Assiut University

研究点 (1)

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