Clinical trial NCT06751407: Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB)
Official title: Comparison of Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB) Applications in the Treatment of Acute Pain After Mastectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Consumption
Demographic Data
Keywords: serratus posterior superior intercostal plane block
pain
breast cancer
mastectomy
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intraoperative opioid consumption.
timeFrame: Intraoperative period
Secondary outcomes:
measure: Postoperative 24-hour numeric rating scale
timeFrame: postoperative 24 hours period
Other outcomes:
Locations:
Study officials:
References: