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临床试验/NCT06356415
NCT06356415尚未招募不适用

Infraclavicular Brachial Plexus Block Using Bupivacaine Alone or in Combination With Dexmedetomidine and Dexamethasone for Hand and Forearm Surgeries, A Randomized, Controlled Trial

Suez Canal University0 个研究点目标入组 40 人开始时间: 2024年5月1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
尚未招募
入组人数
40
主要终点
Onset of sensory block

研究概览

简要总结

Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

详细描述

Brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. A lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (LA). Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. Adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. Objectives: To compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. Patients and Methods: A prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. Patients who will be eligible for the study will be divided into 2 groups. The first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. Expected Results: The success rate, onset time, duration of the block, and possible adverse events.

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
Single (Participant)

盲法说明

The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant

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

  • Age 18-65 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index between 18 and 35 kg/ m2
  • scheduled for forearm and hand surgeries

排除标准

  • Inability to consent to the study
  • Coagulopathy
  • Decompensated chronic hepatic or renal illnesses
  • Allergy to any of the used drugs
  • Pre-existing musculocutaneous/median/radial/ ulnar neuropathy
  • Prior surgery in the infraclavicular fossa

研究组 & 干预措施

Bupivacaine

Active Comparator

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine alone.

干预措施: Bupivacaine injection (Drug)

Bupivacaine+ Dexamethasone+ Dexmedetomidine

Active Comparator

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine combined with dexmedetomidine and dexamethasone.

干预措施: Bupivacaine+ Dexamethasone+ Dexmedetomidine (Drug)

结局指标

主要结局

Onset of sensory block

时间窗: Immediately after the performance of the infraclavicular block

Comparing the number of minutes required to achieve total upper limb sensory blockade following the application of an infraclavicular brachial plexus block that includes both dexmedetomidine and dexamethasone in addition to bupivacaine, as opposed to merely using bupivacaine on its own.

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

Abdelrhman Alshawadfy

Assistant Professor Suez Canal University Faculty of Medicine

Suez Canal University

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