PENG 360°: PENG Block + LIA Nella Endoprotesi di Anca.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Postoperative Analgesic Rescue Doses
研究概览
简要总结
The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are:
- Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery?
- Does the new technique allow participants to move their leg sooner after the operation?
Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea.
Participants who join this study will be randomly placed into one of two groups.
One group will receive the standard spinal anesthesia before their surgery.
The other group will receive the new local anesthesia technique before their surgery.
After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.
详细描述
Study Rationale Standard anesthetic techniques for hip fracture surgery in the target population, which often includes fragile and elderly individuals, present distinct challenges. Both neuraxial (spinal) and general anesthesia can have a significant hemodynamic impact. Furthermore, traditional regional anesthetic techniques like lumbar plexus or femoral nerve blocks, while providing effective analgesia, often result in significant motor and sensory blockade of the lower limb, which can impede early mobilization and rehabilitation.
This study investigates a motor-sparing anesthetic approach. The intervention is based on pericapsular nerve group blocks (A-PENG and PONG), anterior and posterior, which target only the sensory articular branches innervating the hip capsule. This technique, combined with local infiltration analgesia (LIA), aims to provide comprehensive surgical anesthesia and post-operative analgesia without affecting motor function, thereby facilitating immediate post-operative mobilization.
Anesthetic Intervention Details (PENG 360° Arm) Participants randomized to the investigational arm will receive a combination of three injections prior to surgical incision. A convex ultrasound probe will be used for A-PENG and PONG.
- Anterior A-PENG Block: An injection of 20 mL of "plain" anesthetic solution is administered into the fascial plane between the iliopsoas muscle and the hip joint capsule. This solution consists of 10 mL of 0.75% ropivacaine, 10 mL of 2% mepivacaine with 1:200,000 epinephrine, and 2 mg of dexamethasone.
- Local Infiltration Analgesia (LIA): An injection of 20 mL of "diluted" anesthetic solution is used to infiltrate the planned incision line and subcutaneous tissue. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, 1 mg of dexamethasone, and 10 mL of normal saline.
- Posterior PONG Block: With the participant in the lateral decubitus position, an injection of 10 mL of "plain" anesthetic solution is administered into the fascial plane deep to the quadratus femoris muscle. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, and 1 mg of dexamethasone.
During surgery, participants in this arm will receive supplemental oxygen and sedation with propofol, with the depth of anesthesia monitored using a Bispectral Index (BIS) monitor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Scheduled for hip endoprosthesis surgery for femoral fracture with an anterior approach.
- •Age 18 years or older.
- •Willing and able to comply with the study protocol.
排除标准
- •Failure to provide informed consent.
- •Age less than 18 years.
- •Known allergy to local anesthetics or other medications used in the protocol.
- •Presence of infection at the planned injection site.
- •Pre-existing hip prosthesis or prior major surgery on the same hip (e.g., revision surgery).
- •ASA physical status class > IV.
- •Administration of intraoperative opiates or conversion to general anesthesia.
研究组 & 干预措施
PENG 360°
Participants assigned to this arm will receive a motor-sparing anesthetic technique. This consists of three ultrasound-guided injections performed before surgery: an anterior Pericapsular Nerve Group (PENG) block, a Local Infiltration Analgesia (LIA) of the incision line, and a posterior PENG (PONG) block.
干预措施: Pericapsular Nerve Group Blocks with Local Infiltration Analgesia (Procedure)
Spinal
Participants assigned to this arm will receive standard spinal anesthesia. The procedure will be performed according to the center's standard practice and guidelines, with the choice of local anesthetic and dosage at the discretion of the anesthesiologist
干预措施: spinal anesthesia (Procedure)
结局指标
主要结局
Number of Postoperative Analgesic Rescue Doses
时间窗: From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.
The cumulative number of on-demand analgesic doses (2 mg morphine bolus) requested by the participant via an intravenous Patient-Controlled Analgesia (PCA) pump. The total number of requests will be recorded from the pump's memory at 48 hours postoperatively. This is the primary measure for assessing postoperative pain control.
次要结局
- Immediate Postoperative Limb Mobility(Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Within the first 48 hours after surgery.)
- Postoperative Pain Intensity(Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.)
- Length of Hospital Stay(From the date of surgery until date of hospital discharge, assessed up to 30 days.)
研究者
Romualdo Del Buono
Principal Investigator
ASST Gaetano Pini-CTO