Comparison of the Effects of Quadratus Lumborum Block (QLB) Applied for Preemptive Analgesia on Post-operative Pain in Recipients and Donors in Renal Transplantation Surgery With Intravenous Analgesic (IVA) Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Assessment of pain (NRS) level
研究概览
简要总结
This study aims to determine the most effective and long-lasting pain relief method for post-operative analgesia in kidney donor and recipient patients in kidney transplantation programme with the least invasive and least drug administration.
For this reason, it is planned to perform Quadratus lumborum plane block (QLB) in a group of patients who will be kidney donors and kidney recipients in kidney transplantation and who meet the American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3 risk classification between the ages of 18-70 years, and to administer intravenous pain medication without block in another group. It is planned to include at least 84 patients in the Quadratus lumborum plan block (QLB) and Intravenous Analgesia group (IVA) without gender discrimination.
Postoperative Sedation-Agitation assessment and NRS (numeric pain scale) at 1st hour, 2nd, 6th, 12th and 24th hours, as well as possible side effects such as nausea, vomiting, shoulder pain, respiratory depression, bradycardia and hypotension, total amount of opioid analgesics consumed within 24 hours and duration of hospital stay will be observed and recorded.
详细描述
Plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area
- the injection will be administered immediately after general anaesthesia and intubation of the patient
- to monitor compliance with the intervention The medical files and laboratory blood tests of the patients will be examined to determine whether there are any contraindications to the intervention (patients will be excluded in case of bleeding diathesis such as intra-abdominal fluid accumulation, cystic formation, International Normalized Ratio (INR) > 2 or thrombocytopenia).
Blood pressure and heart rate values of the patient and the amount of fentanyl consumed will be recorded throughout the surgery.
The level of sedation-agitation will be evaluated during extubation at the end of surgery.
In the postoperative period, blood pressure, heart rate, pain scoring and the amount of opioid analgesic consumed will be recorded by the anaesthesiologist in the general surgery organ transplant unit and the general surgery specialist and nurses in the organ transplant service at the 1st, 2nd, 6th, 12th, and 24th hours.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years,
- •American Society of Anesthesiologists (ASA) Physical Status Classification System I-III,
- •Being a volunteer kidney recipient or volunteer donor in a kidney transplant programme under general anaesthesia
排除标准
- •Age <18 years or > 70 years
- •American Society of Anesthesiologists (ASA) Physical Status Classification System >III
- •body mass index (BMI) > 35 kg/m2
- •known allergy to local anaesthetics or paracetamol/tramadol
- •presence of preoperative chronic pain
- •presence of accumulated fluid or cystic formation in the abdomen
- •presence of coagulopathy
- •those who are unable to give written consent
结局指标
主要结局
Assessment of pain (NRS) level
时间窗: postoperative 1st, 2nd, 6th, 12th, 24th hours
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
次要结局
- Sedation- agitation level(Will be assessed from immediately after extubation until transfer from the recovery room to the ward.)
- Duration of first analgesic requirement(During the 24 hours postoperative period)
- Blood pressure measurement(It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.)
- Measurement of heart rate(It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.)
- Amount of fentanyl consumed during the operation(During surgery)
- Patient satisfaction assessment(At the end of 24 hours postoperatively)
- Nausea-vomiting(During the 24 hours postoperative period)
- Length of hospital stay(It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first)
- Total postoperative tramadol consumption(Within 24 hours postoperatively)
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital