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临床试验/NCT06690021
NCT06690021尚未招募4 期

Comparing the Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries

Assiut University0 个研究点目标入组 26 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
26
主要终点
total opioid consumption

研究概览

简要总结

Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.

详细描述

Postoperative pain control after spinal surgeries has been a topic of interest for researchers in the past decade. Indeed, poor pain control can not only impact patient satisfaction but also delay rehabilitation and increase healthcare costs.

The thoracolumbar interfascial plane (TLIP) block was defined by Hand et al. for reducing pain following spinal surgery. In this block, the anesthetic drug is administered between the multifidus and longissimus muscles to target the dorsal ramus of the thoracolumbar nerves. The TLIP block was later modified by Ahiskalioglu et al., with the involvement of the administration of a local anesthetic between the longissimus and iliocostalis, which was observed to demonstrate a dermatomal dispersion similar to that by the TLIP block.

Dexmedetomidine is highly specific and highly selective a2-adrenoceptive agonist and it's action is selective to the CNS without the unwanted effect on the CVS that would result from a activation . It has been found that, in many experimental and clinical regional block practices, the addition of dexmedetomidine to the local anesthetic reduces tissue and nerve damage, increases duration of sensory and motor block, and reduces postoperative pain.

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

An independent anesthesiologist randomly using computer-generated random numbers divided the patients into 2 groups :(Group 1 and Group 2). Each group will include 15 patients. We discreetly placed the randomization results in envelopes until the end of the study. The researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation

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

  • • Age >18 years old
  • Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

排除标准

  • • Patient refusal.
  • coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
  • skin lesions or infection at site of proposed needle.
  • known allergy to local anesthetics or dexmedetomidine.
  • patients suffering from mental disease as cannot Assess the Visual Analogue Scale (VAS) that measures pain intensity as, mental retardation & psychosis

研究组 & 干预措施

group 1

Experimental

Classical Thoracolumbar Interfascial Plane Block

干预措施: Dexmedetomidine (Drug)

group 2

Experimental

Modified Thoracolumbar Interfascial Plane Block

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

total opioid consumption

时间窗: 24 hours

To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.

次要结局

  • post operative VAS score(24 hours)

研究者

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

Mohand Mohamed Fathy Salem

resident doctor anesthesia, Intensive Care and Pain Management

Assiut University

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