Analgesic Efficacy of Ultrasound-Guided Transversalis Fascia Plane Block Versus Surgical Wound Infiltration After Open Inguinal Hernia Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 主要终点
- Total opioid consumption within the first 24 postoperative hours
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether two different analgesic techniques - ultrasound-guided Transversalis Fascia Plane Block (TFPB) and surgical wound infiltration - can improve postoperative pain control in adult patients undergoing open inguinal hernia repair.
The key questions that this study aims to answer are:
Does TFPB reduce total intravenous opioid consumption within the first 24 postoperative hours compared with wound infiltration?
Does TFPB improve postoperative pain scores at rest and during movement compared with wound infiltration?
Does TFPB improve patient satisfaction, reduce the need for rescue analgesics, and enhance overall postoperative recovery quality?
If there is a comparison group:
The investigators will compare the effects of TFPB with wound infiltration to determine whether either technique provides superior postoperative analgesia and reduces opioid requirements.
Participants will be asked to:
Undergo open inguinal hernia repair under spinal anesthesia.
Be randomly assigned to one of two groups:
TFPB Group: Receive an ultrasound-guided transversalis fascia plane block with local anesthetic.
Wound Infiltration Group: Receive local anesthetic infiltration performed by the surgeon along the incision line.
Postoperatively:
Report pain scores at defined intervals.
Receive standardized IV analgesia with documentation of opioid consumption.
Allow assessment of rescue analgesic requirement.
Be monitored for adverse events and recovery outcomes.
详细描述
worldwide. Inadequate analgesia in the early postoperative period may lead to delayed mobilization, prolonged hospital stay, and increased opioid consumption. Accordingly, current international guidelines recommend multimodal analgesia strategies and the use of regional anesthesia techniques when appropriate (1). Surgical wound infiltration is a frequently used component of multimodal analgesia in groin surgery; however, its effectiveness may vary depending on the timing of administration, technique, and the homogeneity of local anesthetic spread, and its duration of action is often limited. Recent clinical series continue to report significant postoperative pain and notable opioid requirements following primary unilateral open repair (1).
In recent years, ultrasound-guided fascial plane blocks have gained increasing attention due to their more predictable spread and potential to provide longer-lasting analgesia (2). The TFPB block is a truncal block achieved by injecting local anesthetic between the transversus abdominis muscle and the transversalis fascia, thereby targeting the T12-L1 spinal nerves. This anatomical distribution provides a strong physiological rationale for its use in inguinal region surgery (3).
Several studies have demonstrated that the TFPB can reduce postoperative pain scores and rescue analgesic requirements in pediatric herniotomy and adult groin surgeries (4). However, randomized controlled trials directly comparing the TFPB with surgical wound infiltration in open inguinal hernia repair remain limited. Existing evidence partly stems from comparisons with other fascial plane blocks (e.g., Quadratus Lumborum [QL], Transversus Abdominis Plane [TAP] block or from studies in different types of groin surgery, such as subinguinal varicocelectomy (5-7). Therefore, whether the TFPB provides a clinically meaningful advantage over wound infiltration in open inguinal hernia repair is a clinically relevant question that remains to be definitively answered.
This study aims to compare the contribution of the TFPB and surgical wound infiltration to postoperative analgesia in patients undergoing elective unilateral open inguinal hernia repair. The primary hypothesis is that TFPB will reduce cumulative rescue opioid consumption during the first 24 postoperative hours compared with wound infiltration. The secondary hypotheses are that TFPB will decrease postoperative pain scores, prolong the time to first rescue analgesia, and improve patient satisfaction without increasing the incidence of postoperative nausea and vomiting (PONV) or other adverse events.
articipants will be randomized into one of two intervention arms.
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 (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
- •Age ≥ 18 years
- •Scheduled for elective unilateral open inguinal hernia repair
- •Planned anesthesia: spinal anesthesia
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Able to understand the study procedures and provide written informed consent
排除标准
- •Body mass index (BMI) > 35 kg/m²
- •Known hypersensitivity to local anesthetics used in the study (e.g., bupivacaine) or to analgesic medications
- •Coagulopathy
- •Infection or hematoma at the planned block site
- •Significant systemic disease (such as chronic kidney disease, hepatic failure, chronic obstructive pulmonary disease, etc.)
- •History of chronic pain or long-term analgesic use
- •Inability to use the patient-controlled analgesia system
- •Presence of psychiatric disorders
- •Refusal to participate in the study.
- •Cases with a surgical duration shorter than 30 minutes or longer than 180 minutes were excluded.
研究组 & 干预措施
Surgical Wound Infiltration
At the end of surgery, the operating surgeon will infiltrate a standardized volume and concentration of local anesthetic into the relevant tissue layers of the surgical incision. The infiltration will be performed immediately after skin closure. Participants in this arm will receive the same spinal anesthesia and postoperative analgesia regimen as those in the TFPB group.
干预措施: Surgical Wound Infiltration (Procedure)
Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)
An ultrasound-guided Transversalis Fascia Plane Block will be performed by injecting a standardized volume and concentration of local anesthetic between the transversus abdominis muscle and the transversalis fascia. The block will be administered immediately after spinal anesthesia, prior to postoperative transfer. All other perioperative management and postoperative analgesia protocols will be identical to those in the comparison arm.
干预措施: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB) (Procedure)
结局指标
主要结局
Total opioid consumption within the first 24 postoperative hours
时间窗: 0-24 hours after surgery
Cumulative amount of intravenous rescue opioid (e.g., tramadol or morphine equivalent dose) administered during the first 24 postoperative hours, recorded from the post-anesthesia care unit through postoperative hour 24.
次要结局
未报告次要终点
研究者
Ilke Tamdogan
Assistant Professor
Giresun University