Clinical trial

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

Name
Medipol Hospital 33
Description
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.
Trial arms
Trial start
2023-08-09
Estimated PCD
2024-06-20
Trial end
2024-07-20
Status
Recruiting
Treatment
Analgesia management; group S and C
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.
Arms:
Group C = Control group, Group S = SPSIPB group
Size
60
Primary endpoint
Pain scores (Numerical rating scale-NRS)
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
Eligibility criteria
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,
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. The first group is the SPSIPB group. The second one is the control group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-03-29

1 organization

1 product

1 indication

Organization
Medipol University
Indication
Breast Diseases