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临床试验/NCT07527065
NCT07527065Enrolling By Invitation不适用

Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided TAP Block and Quadratus Lumborum Block in Spinal Anaesthesia for Open Inguinal Hernia Repair

Hitit University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
70
试验地点
1
主要终点
Postoperative Pain Examination with Numeric Rating Scale

研究概览

简要总结

Background Postoperative pain management after open inguinal hernia repair remains a clinical challenge despite spinal anesthesia. Ultrasound-guided fascial plane blocks, such as Transversus Abdominis Plane (TAP) block and Quadratus Lumborum Block (QLB), have been increasingly used as part of multimodal analgesia. This study aimed to compare their effects on postoperative opioid consumption.

Methods After ethics committee approval, 70 patients aged 18-65 years with ASA I-II undergoing elective unilateral inguinal hernia repair were included in this prospective, randomized study. Patients were allocated into two groups: Group Q (QLB) and Group T (TAP). Blocks were performed preoperatively under ultrasound guidance using the in-plane technique with 30 mL of 0.25% bupivacaine. Block success was defined as sensory blockade at T10-L1 dermatomes at 30 minutes.

All patients received spinal anesthesia at the L3-L4 level with 12.5 mg of 0.5% isobaric bupivacaine. Postoperatively, patient-controlled analgesia (PCA) with tramadol was administered for 24 hours. Pain scores were assessed using the Numeric Rating Scale (NRS) at PACU and at 1, 3, 6, 12, 18, and 24 hours. Opioid consumption was recorded at 0-1, 2-12, 12-24 hours, and cumulatively over 24 hours. Postoperative side effects were also evaluated.

Results Both QLB and TAP block provided effective postoperative analgesia. There were no significant differences between the groups in terms of total 24-hour opioid consumption or NRS pain scores at measured time points. However, QLB demonstrated a trend toward prolonged analgesic duration and wider dermatomal spread.

Conclusion Both TAP and QLB are effective adjuncts to spinal anesthesia for postoperative analgesia in unilateral inguinal hernia repair. While QLB may offer broader and longer-lasting analgesia, its superiority over TAP block in reducing opioid consumption was not statistically significant.

详细描述

Aim: Transversus abdominis plane (TAP) block has been shown to provide effective postoperative analgesia in open inguinal hernia surgeries. However, although there are studies reporting that the quadro-iliac plane block provides adequate analgesia in the lower abdomen, there is no study specifically investigating its use in open inguinal hernia repair cases. The aim of this study was to contribute to the literature by determining which method is more effective for postoperative analgesia after open inguinal hernia surgery and whether it reduces opioid-related complications.

Introduction Open inguinal hernia repair is a common surgical procedure that can be performed under general or regional anesthesia. Although considered minimally invasive, open inguinal hernia repair may cause moderate to severe postoperative pain and may even progress to chronic pain, which can be equally distressing. Incisional pain is the most important factor determining how soon patients can return to work after surgery. Postoperative chronic pain, with a reported incidence ranging % 10, is one of the major complications of surgical hernia repair . Severe pain may delay postoperative ambulation, reduce patient satisfaction, and contribute to the development of chronic pain; these conditions are also associated with increased pulmonary and cardiac complications. Moreover, inadequate pain control may prolong hospital stay.

Postoperative pain arises from multiple causes. In open inguinal hernia repair, the predominant pain experienced by patients is a combination of visceral and incisional pain. Postoperative pain is a common complication that may trigger a neuroendocrine stress response characterized by increased secretion of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system . The use of regional anesthesia and analgesia as part of multimodal analgesia has been shown to reduce the neuroendocrine stress response associated with pain and surgical trauma. Therefore, pain management should be approached using multimodal analgesia.

To reduce postoperative pain following inguinal hernia repair, nonsteroidal anti-inflammatory drugs, paracetamol, opioids, local anesthetics, and various regional anesthesia techniques are commonly used. However, opioids may cause adverse effects such as postoperative nausea and vomiting, constipation, and respiratory depression. Multimodal analgesia techniques have been widely implemented in postoperative pain management . Truncal blocks-including the transversus abdominis plane block (TAPB), quadratus lumborum block (QLB), rectus sheath block, and hernia block-play an important role in multimodal analgesia.

The anterolateral abdominal wall consists of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles. The transversus abdominis plane is an anatomical plane located between the internal oblique and transversus abdominis muscles and contains the thoracolumbar nerves (T6-L1). The anterior and lateral abdominal walls are innervated by the anterior rami of the T7-T12 and L1 thoracoabdominal nerves. Therefore, injection of local anesthetic into the transversus abdominis plane provides sensory blockade from T7 to L1. The TAP block can be used as part of the analgesic regimen in various abdominal surgeries, including appendectomy, hernia repair, laparotomy, laparoscopic procedures, cesarean section, abdominal hysterectomy, pyloromyotomy, major abdominal wall surgery, and colostomy formation . In previous studies, Okur, Avelina, and colleagues demonstrated that TAP block provides superior analgesia in patients undergoing open inguinal hernia repair.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Will undergo Open Inguinal Hernia Repair
  • The American Society of Anesthesiologists (ASA) physical classification is 1-
  • The volunteer has read and accepted the consent form
  • Body mass index (BMI) <35

排除标准

  • Body mass index (BMI) >35 kg/m²
  • American Society of Anesthesiologists (ASA) physical status III-V
  • Inability to assess pain using the Numeric Rating Scale (NRS)
  • Known allergy to the local anesthetic or the planned analgesic agent
  • Self-reported pregnancy or breastfeeding
  • Age <18 or >65 years
  • Uncontrolled anxiety
  • Alcohol or substance abuse
  • Neuromuscular disease or peripheral neuropathy
  • Use of high-dose opioid medication within three days prior to surgery widespread chronic pain
  • Diabetes mellitus
  • Hepatic or renal insufficiency
  • Coagulation disorders
  • Current use of anticoagulant therapy
  • Infection at the site of peripheral block needle insertion
  • Ireducible, incarcerated, strangulated, or recurrent inguinal hernia
  • Inability to communicate in Turkish
  • Technical problems during the use of the patient-controlled analgesia (PCA) device
  • NRS score persistently above 7 for four consecutive hours despite the planned multimodal analgesia regimen
  • Inability to understand or use the Verbal Rating Scale for pain assessment and the Quality of Recovery-15 (QoR-15) questionnaire
  • Termination of surgery before completion for any reason.

研究组 & 干预措施

Group T (Transversus Abmoninis Plane Block)

Active Comparator

With the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers.

干预措施: Transversus Abmoninis Plane Block (Procedure)

Group Q ( Quadro-Iliac Plane Block)

Active Comparator

With the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected.

干预措施: Quadro-Iliac Plane Block (Procedure)

结局指标

主要结局

Postoperative Pain Examination with Numeric Rating Scale

时间窗: 24 hours

Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position).

次要结局

未报告次要终点

研究者

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

Zeynep Kaya

Resident doctor

Hitit University

研究点 (1)

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