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Serratus Posterior Superior Interfascial Plane Block for Breast Surgery

The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Pain Control in Female Patients Underwent Mastectomy and Axillary Lymph Node Dissection: A Randomized, Prospective, Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05972083
Enrollment
60
Registered
2023-08-02
Start date
2023-08-09
Completion date
2024-10-30
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Diseases

Keywords

Mastectomy and axillary dissection surgery, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block

Brief summary

Regional techniques can be used for postoperative pain control following breast surgery. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions 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. With the SPS block, these nerves are blocked and analgesia is provided.

Detailed description

Mastectomy and axillary lymph node dissection are among the most frequently performed surgeries today, and pain control is an important problem affecting patient comfort in the postoperative period in these patients. Postoperative pain is an acute pain associated with the inflammatory process that occurs due to surgical trauma and gradually decreases with tissue healing. Several analgesic drugs such as opioids are used to prevent this pain, but these agents have many unwanted side effects. Successful postoperative analgesia occurs in the patient due to pain; it is a known fact that it prevents many of the effects such as not being able to breathe easily and delayed mobilization. Regional techniques can be used for postoperative pain control following breast surgery. Ultrasound (US) guided serratus posterior superior block (SPSIPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions 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. With the SPS block, these nerves are blocked and analgesia is provided. In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were clearly stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. In this study, our aim is to investigate the efficacy of US-guided SPSIPB for postoperative analgesia management after mastectomy and axillary lymph node dissection surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate the need for rescue analgesics, block-related complications, dermatome level, and side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Interventions

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.

Intervention model description

There are two models for this study. The first group is the SPSIPB group. The second one is the control group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) classification I-II * Scheduled for mastectomy and axillary dissection surgery under general anesthesia

Exclusion criteria

* receiving anticoagulant treatment, * known study drugs allergy, * opioid addiction * infection of the skin at the site of the block, * pregnancy or lactation,

Design outcomes

Primary

MeasureTime frameDescription
Pain scores (Numerical rating scale-NRS)Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hoursThe primary aim is to compare NRS at the postoperative 1st h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded

Secondary

MeasureTime frameDescription
Need for rescue analgesia (meperidine)Postoperative 24 hours periodThe secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Adverse eventsPostoperative 24 hours periodThe secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Dermatomal analysesPostoperative 1st hourThe secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026