Efficacy of the Erector Spinae Plane (ESP) Block for Quality of Recovery in Posterior Thoraco-Lumbar Spinal Decompression Surgery: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- QoR 15 score
研究概览
简要总结
Spinal Surgery can be associated with significant post operative pain. This can be a considerable source of morbidity, resulting in a longer duration of in- hospital stay and increasing opiate requirements. As a result the patient experiences a more arduous recovery process.
Recently a new form of Regional Anaesthesia has been described for patients undergoing Spinal surgery. The Erector Spinae Plane Block involves depositing Local Anaesthetic under Ultra Sound guidance on top of the Transverse Process of the Spine and deep to the Erector Spinae Muscle. Patients who have had this procedure report lower pain scores and have a lesser opiate requirement in the post operative period.
详细描述
This study will test the hypothesis that patients receiving ESP Block have higher QoR-15 scores and better post operative analgesia in comparison with patients receiving standard care after Spinal Surgery.
Objectives & endpoints / outcome measures
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The Primary outcome in this study will be the patient centred QoR-15 score among ESB and Control patients;
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Secondary outcomes will be:
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Area under the VRS pain score versus time (24 hr post-op);
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VRS pain scores at 1 hr, 4 hr, 12 hr, 24 hr postop;
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time to administration of first rescue analgesia after the block;
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documentation of adverse events : hypotension, pruritus, nausea and vomiting
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DAH -30 Days at home at 30 Days
Proposed sample size The established minimum clinically important difference in QoR-15 is 8.0 and the SD of QoR-15 scores after major surgery is in the order of 10 [range of QoR score is 1-150]. Therefore, assuming Type I error = 0.05 and Type II error = 0.2 (80% power to detect this difference), then n=25 patients needed in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants providing written informed consent, ASA grade 1- 4, age group 18 and over undergoing Posterior approach Spinal surgery involving 2 or more levels of decompression in the lumbar or thoracic regions.
排除标准
- •Absence of informed written consent, pre existing infection at block site, severe coagulopathy, allergy to local anaesthesia, , previous history of opiate abuse, pre existing chronic pain condition, pre-existing dementia [because of need to co-operate in completing QoR-15 score day after surgery], decompression involving cervical levels of vertebrae, decompression due to queried or confirmed malignancy
结局指标
主要结局
QoR 15 score
时间窗: 24 hours post operatively
a objective assessment of quality of recovery post surgery
次要结局
- AUC of VRS Pain score versus time(24 hours post op)
- time to administration of first rescue analgesia after the block(24 hours post op)
研究者
Dylan Finnerty
Clinical Lecturer in Anaesthesia
Mater Misericordiae University Hospital