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临床试验/NCT03043495
NCT03043495Unknown4 期

The Optimal Dose Of Dexamethasone To Be Used As An Adjuvant To Low Volume Bupivacaine Ultrasound Guided Supraclavicular Brachial Plexus Block. A Randomized Controlled Double Blinded Dose Ranging Study

Eslam Ayman Mohamed Shawki1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

A dose-ranging study to test various doses of Dexamethasone (2, 4 & 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased random blood sugar levels)

详细描述

Brachial plexus nerve blocks (BPBs) for upper extremity surgery provide superior analgesia and reduce opioid consumption. Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery. Ultrasound guided single injection (SI) and triple injection (TI) techniques were found to provide the same degree of surgical anesthesia at 30 minutes while the TI technique needed more time to perform.

Many studies were conducted to examine the effect of perineural Dexamethasone as a local anesthetic adjuvant in low volume peripheral nerve blocks were it was found to increase the mean duration of analgesia (sensory block) with short, medium and long acting local anesthetics as well as the duration of motor blockade, with a reduction in pain scores at rest during the intermediate (8-12 h) and late (24 h) postoperative periods and in movement at all times. At 24 postoperative hours, cumulative morphine consumption and the rate of nausea or vomiting were also reduced without any reported related serious adverse effects, also the value of its concomitant intravenous use in prolonging the duration of analgesia after regional blocks was studied with promising results that can sometimes be compared to the perineural route but more short-lived and associated with higher increase in blood glucose levels. Dexamethasone's mechanism of action may result from decreased nociceptive C-fibre activity via a direct effect on glucocorticoid receptors and inhibitory effect on potassium channels.(8) Other authors suggest a local vasoconstrictive effect, resulting in reduced local anaesthetic absorption or a systemic anti-inflammatory effect following vascular uptake of the drug.

A debate exists whether perineural corticosteroids are harmful or not, but reports of neurotoxicity seem to be related mainly to the preservative benzyl alcohol and the vehicle polyethylene glycol found in some preparations, also may be related to the presence of insoluble steroid particulate matter in the injectate. Dexamethasone is non-particulate and can be found in a preservative-free formulation. In addition, no significant long-term electrophysiological, behavioural or histological effects for corticosteroids were identified on rat sciatic nerve tissue even some data suggest dexamethasone may actually be neuroprotective. In reality, perineural corticosteroid injections with and without preservative are widely used throughout the world.

Various doses of Dexamethasone were used in local anaesthetic mixtures in regional blocks in various studies, including 4, 5, 8 and 10 mg. In a recent review & meta-analysis by E. Albrecht and his colleagues, sub-group analysis revealed no association between the total dose of perineural Dexamethasone and the mean increase in duration of analgesia showing that Dose-finding studies are needed to better define the optimal balance between dose, effects and side-effects, particularly at doses lower than 4 mg.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The patient and the attending anesthetist who will manage the patient intra-operatively and perform the block, will be blinded to the patient group allocation All recorded values will be obtained by personnel blinded to the group allocation of the patient.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing surgeries in the upper limb (arm, forearm or hand)

排除标准

  • Coagulopathies (with prothrombin concentration less than 60% or INR more than 1.5)
  • In-ability to postpone anti-coagulation medications.
  • Infection or injury or a lesion at the block site.
  • Suspected cervical vertebral column injury necessitating using a neck collar.
  • A compromised lung on the contralateral side of the block (Pneumothorax, hemothorax or Pneumonectomy).
  • Traumatic vascular injuries or operative interventions (Surgical harvesting) involving arteries of the upper limb on the operative side.
  • Patients with communication difficulties.
  • Hypersensitivity to local anesthetics and/or Dexamethasone.
  • Patients on perioperative intravenous (IV) steroids.

研究组 & 干预措施

Group A

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline.

干预措施: Ultrasound guided supraclavicular brachial plexus block (Procedure)

Group A

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline.

干预措施: Dexamethasone (Drug)

Group B

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline.

干预措施: Ultrasound guided supraclavicular brachial plexus block (Procedure)

Group B

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline.

干预措施: Dexamethasone (Drug)

Group C

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone.

干预措施: Ultrasound guided supraclavicular brachial plexus block (Procedure)

Group C

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone.

干预措施: Dexamethasone (Drug)

Group Control

Active Comparator

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.

干预措施: Ultrasound guided supraclavicular brachial plexus block (Procedure)

结局指标

主要结局

Duration of analgesia

时间窗: 24 hours

The time between injection of Local anesthetic mixture during performing the block and time of administration of the first dose of rescue analgesia at VAS equal or more than 4

次要结局

  • Duration of motor block(24 hours)
  • Patient Satisfaction score(24 hours)
  • Incidence of PONV(24 hours)
  • Incidence of complications(24 hours)
  • Random Blood glucose levels(24 hours)

研究者

发起方
Eslam Ayman Mohamed Shawki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eslam Ayman Mohamed Shawki

Lecturer of anesthesia, SICU & Pain Management

Cairo University

研究点 (1)

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