Clinical trial

The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: A Randomized, Prospective, Controlled Study

Name

Medipol Hospital 34

Description

Regional techniques can be used for postoperative pain control following VATS. 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

2024-06-30

Status

Recruiting

Treatment

Analgesia management; group S and C

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. 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

Primary endpoint

Opioid consumption (Fentanyl PCA)

Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Eligibility criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) classification I-III * Scheduled for VATS under general anesthesia Exclusion Criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who do not accept the procedure

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

2024-04-02

1 organization

1 product

1 indication

Organization

Medipol University

Product

Analgesia management

Indication

Lung Diseases