The Effects of Transversalis Fascia Plane Block on Opioid Consumption in Patients Undergoing Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total opioid consumption during the first 24 hours postoperatively
研究概览
简要总结
This study aims to evaluate whether a regional anesthesia technique called the transversalis fascia plane block (TFPB) can improve pain control after hand-assisted laparoscopic donor nephrectomy (HALDN), a minimally invasive surgery performed in living kidney donors.
Although HALDN is less invasive than open surgery, patients often experience significant pain after the operation, mainly due to the surgical incisions in the lower abdomen and trocar entry sites. Poorly controlled pain can delay recovery and increase the need for opioid pain medications, which may cause side effects such as nausea, vomiting, itching, and sedation.
The transversalis fascia plane block is an ultrasound-guided regional anesthesia technique in which a local anesthetic is injected into a specific tissue plane in the lower abdominal wall. This injection temporarily blocks pain signals from nerves supplying the lower abdomen and groin area. The technique has been shown to reduce pain and opioid use after various lower abdominal surgeries and is considered minimally invasive and safe when performed under ultrasound guidance.
In this study, patients undergoing HALDN will be randomly assigned to one of two groups. One group will receive standard general anesthesia only, while the other group will receive general anesthesia plus a transversalis fascia plane block using a local anesthetic (bupivacaine). All patients will receive the same standard pain treatment after surgery, including paracetamol and patient-controlled morphine.
The main goal of the study is to compare the amount of opioid pain medication used during the first 24 hours after surgery between the two groups. Secondary outcomes include pain scores measured using the Numeric Rating Scale (NRS), the frequency of opioid-related side effects, and patient satisfaction with pain control.
The results of this study may help determine whether adding the transversalis fascia plane block to standard anesthesia can provide better pain relief, reduce opioid consumption, and improve comfort and recovery in living kidney donors.
详细描述
Study Objective and Hypothesis The primary objective of this prospective, randomized controlled clinical trial is to evaluate the analgesic efficacy of the transversalis fascia plane block (TFPB) in patients undergoing hand-assisted laparoscopic donor nephrectomy (HALDN). The study hypothesizes that the addition of ultrasound-guided TFPB using a local anesthetic will result in lower postoperative opioid consumption and reduced postoperative pain scores, as measured by the Numeric Rating Scale (NRS), during the first 24 hours after surgery.
Background and Rationale HALDN is widely used as a minimally invasive surgical technique for living kidney donation. Despite its minimally invasive nature, postoperative pain remains a significant clinical issue and may negatively affect patient recovery, mobilization, and overall satisfaction. Pain following HALDN is primarily attributed to trocar insertion sites and the lower abdominal incision required for kidney extraction.
Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to improve postoperative pain control and reduce opioid requirements. However, an optimal regional anesthesia technique for HALDN has not yet been established.
The transversalis fascia plane block is an ultrasound-guided regional anesthesia technique in which local anesthetic is injected between the posterior surface of the transversus abdominis muscle and the transversalis fascia. This approach targets the thoracolumbar nerve branches at the T12-L1 level, including the ilioinguinal and iliohypogastric nerves, which are responsible for sensory innervation of the lower abdominal wall and groin. TFPB has been shown to provide effective analgesia following inguinal hernia repair, lower abdominal surgeries, and urologic procedures.
When performed under ultrasound guidance, TFPB is considered a safe and minimally invasive technique. Potential complications are rare and may include block failure, local anesthetic systemic toxicity, or inadvertent injury to surrounding structures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Approved by the transplant committee for living kidney donation
- •Scheduled for hand-assisted laparoscopic donor nephrectomy (HALDN)
- •Able to understand study procedures and provide written informed consent
排除标准
- •Known allergy to any medications used in the study (e.g., local anesthetics, opioids)
- •Chronic opioid use or use of opioid receptor agonists
- •Inability to communicate effectively (e.g., cognitive impairment, language barrier)
- •Chronic organ failure or major organ dysfunction
- •Refusal or inability to provide informed consent
- •Foreign nationality (if follow-up or consent is restricted)
- •American Society of Anesthesiologists (ASA) physical status ≥ III
研究组 & 干预措施
Group A
General anesthesia without regional block
Group B
General anesthesia + Ultrasound guided Transversalis Fascia Plane Block (with local anesthetic)
干预措施: Ultrasound-guided transversalis fascia plane block (Procedure)
结局指标
主要结局
Total opioid consumption during the first 24 hours postoperatively
时间窗: 24 hours after surgery
Total cumulative opioid consumption (morphine-equivalent dose) within the first 24 hours following hand-assisted laparoscopic donor nephrectomy.
次要结局
- Postoperative pain scores using the Numeric Rating Scale (NRS)(24 hours postoperatively)
- Incidence of opioid-related adverse effects(24 hours postoperatively)
- Rescue analgesic use(Time Frame: 24 hours postoperatively)
研究者
Yasemin Sincer
Medical Doctor
Koç University