Evaluation of the Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia Management in Patients Undergoing Arthroscopic Shoulder Surgery
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
- 2
- 主要终点
- Opioid consumption (Fentanyl PCA)
研究概览
简要总结
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use.
Serratus posterior superior interfascial plane block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. It has been reported that SPSIPB provides effective shoulder analgesia.
详细描述
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort, prevents early rehabilitation, and affects the functional outcome after surgery. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use. Regional techniques can be used for postoperative pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided serratus posterior superior block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on the principle of injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. Analgesia is provided by blocking these nerves with the SPS block. Tulgar et al. reported in their cadaver study that the spread of the serratus posterior superior interfascial plane block; staining in the superficial fascia of the trapezius muscle was observed only on the left side at the 7-10th intercostal levels, but not on the right. There was significant staining deep in the trapezius muscle on both sides. Both the surface and the skin of the rhomboid major were clearly stained, while only the skin of the rhomboid minor was stained; SPSP block will provide successful analgesia in procedures involving the thoracic region such as breast surgery, thoracic surgery, and shoulder surgery.
In this study, the investigators aim to evaluate the analgesic efficacy of SPSIPB by comparing the control group in patients who underwent arthroscopic shoulder surgery.
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, Outcomes Assessor)
盲法说明
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-II
- •Scheduled for arthroscopic shoulder surgery under general anesthesia
排除标准
- •history of bleeding diathesis,
- •receiving anticoagulant treatment,
- •known local anesthetics and opioid allergy,
- •infection of the skin at the site of the needle puncture,
- •patients who do not accept the procedure
研究组 & 干预措施
Group SPSIPB = SPSIPB group
SPSIPB will be performed
干预措施: Postoperative analgesia management (Drug)
Group SPSIPB = SPSIPB group
SPSIPB will be performed
干预措施: SPSIPB block (Drug)
Group Control
Conventional analgesia management will be performed
干预措施: Postoperative analgesia management (Drug)
结局指标
主要结局
Opioid consumption (Fentanyl PCA)
时间窗: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
The primary aim is to compare postoperative opioid consumption from the PCA device.
次要结局
- Pain scores (Numerical rating scale-NRS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours)
- Need for rescue analgesia (meperidine)(Postoperative 24 hours period)
- Adverse events(Postoperative 24 hours period)
研究者
Bora Bilal
Principal Investigator
Kahramanmaras Sutcu Imam University
