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临床试验/NCT02936427
NCT02936427Unknown3 期

The Effects and Dose Response of Dexamethasone on Intercostal Nerve Blocks With Bupivicaine in Post Thoracic Surgery Patients

University College Dublin1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
Amount of analgesia used in 24hrs

研究概览

简要总结

Post-op analgesia is the most important part of early and safe patient recovery in thoracic surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly improved with optimal pain control and complications and length of stay are minimized. Most post-op thoracic complications are from decreased respiratory effort, failure to clear secretions and pulmonary infections from retained sputum with subsequent sequelae. Good post-operative analgesia not only prevents these complications but also considerably enhances early mobilization and thus, decreased hospital stay and efficient resource allocation. Early post-operative pain is also associated with late and chronic post thoracotomy pain syndromes which can be debilitating.

Pain following thoracic surgery is different to the standard surgical incision pain and is due to intercostal nerve damage, compression or traction injury to the nerve. This occurs with the incision, rib retraction, and is compounded by the on-going need for respiratory effort. The approach to managing this pain is multi-modal analgesia. The standard regimen stretches from preemptive analgesia and preoperative placement of thoracic epidurals to post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as anti-convulsants like pregabalin. However, opioid use has well-known side effects including central nervous system (CNS) and respiratory depression which unfortunately delay mobility and recovery. This has motivated opioid-sparing strategies.

The investigators study aims to assess whether the addition of perineural dexamethasone (a steroid) to the current practice of local anaesthetic wound catheters increases the efficacy and duration of analgesia provided.

详细描述

Recent years have seen the importance of early mobility and respiratory toilet to minimise complications and hospital stay. Newer methods of pain relief with fewer systemic effects have become even more important. Continuous wound infiltration catheters (CWI's) aim to deliver local anaesthetic agents directly into the wound (4). This technique goes back to 1994, and has been established in this hospital and is used in a non-structured manner in thoracic surgery. Recent studies have demonstrated that the addition of dexamethasone (a steroid) to local anaesthetic agents in similar nerve blocks significantly improves the analgesic affect and prolongs the duration of the analgesia. To the best of the investigators knowledge this has not been tested in a thoracic surgery cohort of patients, though it has been tested safely and effectively in the thorax in healthy volunteers and in postoperative analgesia in abdominal and musculoskeletal post op patients. The investigators aim is to assess whether the addition of perineural dexamethasone to the local anaesthetic in CWI's is superior to the local anaesthetic alone in thoracic post operative patients, and at which dose. They also want to assess the levels of pain experienced 1 month post op to evaluate the potential effect of dexamethasone on post thoracoscopy pain syndrome.

The investigators aim is to compare the use of local anaesthetic agent in combination with perineural dexamethasone with the current practice of local anaesthetic alone at relieving pain in the immediate post op pain period. The investigators also want to assess whether the 8mg dose of dexamethasone used in similar studies is the optimal dose or whether a similar effect can be observed at a smaller dose of 4mg.

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
Single (Participant)

入排标准

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

入选标准

  • Consenting
  • undergoing VATS procedure

排除标准

  • Refusal to consent
  • Equipment failure
  • Allergic reactions to local anaesthetic agent
  • Incipient agents or opioid
  • Patients on pre-existing long-term opioid use
  • Any other concomitant or surgery within 2 weeks of the thoracic surgery

研究组 & 干预措施

Dexamethasone 4mg

Experimental

Participants will receive 4mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters.

干预措施: Dexamethasone (Drug)

Dexamethasone 8mg

Experimental

Participants will receive 8mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Amount of analgesia used in 24hrs

时间窗: 0- 24hrs from surgery

Cumulative analgesia used over 24hrs

Amount of analgesia used in 1 month from date of surgery

时间窗: 0hrs - 1 month from surgery

Cumulative analgesia used over 1 month

Amount of analgesia used in 48hrs

时间窗: 0-48hrs from surgery

Cumulative analgesia used in 48 hrs

次要结局

  • Pain reported by patient at 24hrs(recording of patients level of pain 24hrs post op)
  • Pain reported by patient at 48hrs(recording of patients level of pain 48hrs post op)
  • Pain reported by patient 1 month post op(recording of patients level of pain 1 month post op)

研究者

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

Mark Murphy

Surgical SHO

University College Dublin

研究点 (1)

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