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临床试验/NCT06673979
NCT06673979招募中不适用

Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
220
试验地点
1
主要终点
NRS 1 hour

研究概览

简要总结

Chronic postoperative pain (CPP) is typically defined as pain persisting for 3 months or more after surgery[1]. CPP is a common and increasingly prevalent morbidity, leading to long-term psychological issues, reduced quality of life, and impaired functionality[2]. To reduce the incidence of CPP, high-risk patients are identified, and various surgical techniques, pharmacological agents, and regional anesthesia techniques are employed[3].

The primary aim of our study is to scale chronic pain at 1 hour, 3 months, and 1 year post-nephrectomy using the Numeric Rating Scale (NRS), ranging from 0 to 10. The secondary aim is to evaluate the effects of factors influencing chronic postoperative pain on the NRS scores.

详细描述

Patients gender, age, height(m), weight(kg), body mass index(kg/m2), diagnosis, smoking and alcohol history, comorbidities, surgical technique and duration, complications, lymph node dissection, thrombectomy, adrenalectomy, amount of bleeding(cc), need for blood transfusion, need for intensive care, analgesia technique used, amount of opioids and non-opioid analgesics used perioperatively, amount of vasopressors used, heart rate(bpm) and mean arterial pressure(mmHg) at induction, post-intubation, post-extubation, and 1 hour postoperatively, presence of postoperative pain, chronic analgesic use history(more than 3 uses per week), presence of fibromyalgia, frequent urinary tract infections, diagnosed with central sensitization disorders, bruxism, depression-panic attacks, allergic asthma, irritable bowel syndrome, and migraines will be recorded. The effects of these factors on NRS scores at 1 hour, 3 months, and 1 year postoperatively will be examined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-90 years,
  • ASA I-IV,
  • undergoing elective nephrectomy under general anesthesia will be included in the study.

排除标准

  • Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.

结局指标

主要结局

NRS 1 hour

时间窗: 1 hour after the end of the surgery

The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain). Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free

NRS 1 year

时间窗: 1 year after the surgery

The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain). Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free

NRS 3 months

时间窗: 3 months after the surgery

The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain). Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free

次要结局

  • age(At the time of preoperative assesment)
  • height(At the time of preoperative assesment)
  • BMI(At the time of preoperative assesment)
  • smoking(At the time of preoperative assesment)
  • Amount of opioid and non-opioid analgesics used perioperatively(At the time of perioperative assesment)
  • Gender(At the time of preoperative assesment)
  • surgical technique(At the time of perioperative assesment)
  • surgical duration(The time recorded at the end of the surgery will be reported)
  • Value of postoperative acute pain score on NRS score(1 hour postoperative period)
  • Comorbidities(At the time of preoperative assesment)
  • additional procedures next to the nephrectomy(At the time of perioperative assesment)
  • need for blood transfusion(At the time of perioperative assesment)
  • need for intensive care units(At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported)
  • Analgesia technique(At the time of perioperative assesment)
  • Amount of vasopressors used(At the time of perioperative assesment)
  • Chronic analgesic use history(1 year before the operation)
  • Clinical conditions that will be reported under the title of central sensitization disorder(At the time of preoperative assesment)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

İlayda Bilgili Altuntaş

Principal investigator, Anesthesiology and Reanimation, Physician

Istanbul University - Cerrahpasa

研究点 (1)

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