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临床试验/NCT06221319
NCT06221319已完成不适用

EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON RECOVERY QUALITY AFTER TOTAL HIP ARTHROPLASTY

Konya City Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Quality of recovery-15T

研究概览

简要总结

Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. We think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA through the QoR-15 score and to evaluate its effect on postoperative pain.

详细描述

Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. The investigators think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA, through the QoR-15 score, and to evaluate its effect on postoperative pain.

Anesthesia Technique and Analgesia Protocol a standard to measure postoperative pain severity after THA, and intravenous injection is used as a standard in patients with no contraindications within the scope of the multimodal analgesia protocol. paracetamol 1 gr. 3x1 + Dexketoprofen 50 mg 2x1 and when NRS is 3 and above, 1mg/kg tramadol is administered as a rescue analgesic. In addition, ESPB is applied to patients as a part of multimodal analgesia after THA surgery, unless there are contraindications in the hospitals where the study will be conducted. And 4 mg IV is routinely administered to patients with postoperative nausea and vomiting. Ondansetron is administered . All patients will receive routine monitoring and routine anesthesia management. 20 gauge to patients Intravenous ( IV ) cannulation is provided and 15ml/kg/ h Isotonic fluid will be started. The spinal anesthesia will be applied to the patients by administering 3cc of 0.5% bupivacaine through the L3-L4 or L4-L5 intervertebral space. Patients will then be released to the surgical team for THA surgery. After the surgical procedure is completed, patients will be transferred to the postanesthetic care unit (PACU) for observation. S-ESPB will be applied to patients in Group S

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 (Investigator)

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 who will undergo unilateral THA
  • Spinal anesthesia
  • 18-80-year-old patients
  • Patients with ASA I-IV
  • Patients who will stay in the hospital for at least 24 hours

排除标准

  • Patients who do not want to give consent
  • Patients under 18 years of age and over 80 years of age
  • Patients for whom regional anesthesia is contraindicated
  • Patients with confusion
  • Patients with ASA V and above
  • Patients with abnormal bleeding profile
  • Patients using anticoagulants
  • Patients with infection in the area to be treated
  • Emergency cases

结局指标

主要结局

Quality of recovery-15T

时间窗: One day

The primary evaluation criteria will be the recording of QoR -15 scores, which indicate the quality of recovery of patients before and at 24 hours after surgery .

次要结局

未报告次要终点

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Halit Satici

Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D

Konya City Hospital

研究点 (2)

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