跳至主要内容
临床试验/NCT06751407
NCT06751407尚未招募不适用

Comparison of Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB) Applications in the Treatment of Acute Pain After Mastectomy

Ankara Etlik City Hospital0 个研究点目标入组 50 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Intraoperative opioid consumption.

研究概览

简要总结

Breast cancer is the most common malignancy in women; one of the mainstays of breast cancer treatment is surgery, and modified radical mastectomy is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abrigation during modified radical mastectomy, but their applications are limited due to the complex nature of the procedures and serious complications. In recent years, regional nerve blocks, including intercostal nerve block, erector spinae plane block (ESPB), and paravertebral block, PECS I-II block, serratus anterior plane block (SAPB), and Serratus Posterior Superior Intercostal Plane Block (SPSIPB), have been applied for the treatment of postmastectomy pain in breast cancer patients. SPSIPB has been frequently used for the treatment of acute pain in the postoperative period following surgeries in the thoracic region. SPSIPB is placed on the spine of the scapula in the sagittal plane to identify the second and third ribs under USG guidance. After visualizing the trapezius and serratus posterior superior (SPS) by moving medially to the upper medial border of the scapula, a block is applied to the depths of the SPS from above the 3rd rib. The applied local anesthetic solution spreads under the SPS muscle. Ipsilateral postoperative analgesia is provided with SPSIPB. SPSIPB can be applied on the 3rd rib in one go, or on the 3rd and 4th ribs in two go. Thus, the local anesthetic solution can be distributed more effectively and more effective postoperative analgesia can be provided.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • •1-Those between the ages of 18-80
  • •2.Those with ASA score I-II-III
  • •3.Those with body mass index (BMI) between 18-40
  • •4.Patients who underwent Single-Level or Two-Level SPSIPB together with mastectomy in the operating room

排除标准

  • •Those under 18 and over 80
  • •Those with ASA score IV and above
  • •Those with advanced co-morbidities
  • •Those with a history of bleeding diathesis
  • •Patients with infection in the area where the block will be performed
  • •Those with BMI under 18 and over 40
  • •Patients who underwent surgery under emergency conditions

研究组 & 干预措施

Group Single level SPSIPB

Active Comparator

The procedure will be performed with the patient in the prone position in the preoperative period. After the scapula is slightly shifted laterally, the US probe is held sagittally at the upper corner of the scapula spine, and the 3rd rib and the serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and entered between the serratus posterior superior and the 3rd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be used.

干预措施: Single level SPSIPB (Procedure)

Group Two-level SPSIPB

Active Comparator

The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 2nd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 10 ml of 0.25% bupivacaine will be used. Then, the US probe will be held sagittally in the medial part of the scapula spine, and the 4th rib and serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 4th rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block site is confirmed, 10 ml of 0.25% bupivacaine will be used. A total of 20 ml of 0.25% bupivacaine will be used.

干预措施: Two-level SPSIPB (Procedure)

结局指标

主要结局

Intraoperative opioid consumption.

时间窗: Intraoperative period

Intraoperative opioid consumption will be recorded.

次要结局

  • Postoperative 24-hour numeric rating scale(postoperative 24 hours period)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Seyyid Furkan Kına

Principal Investigator

Ankara Etlik City Hospital

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