Health TrialsbyHealthPanel

Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block

ConditionsShoulder PainShoulder Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedipol University

About this trial

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.

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. It has been reported that SPSIPB provides effective analgesia after shoulder surgery.

The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) classification I-II

Scheduled for arthroscopic shoulder surgery under general anesthesia

Disqualifiers

history of bleeding diathesis,

receiving anticoagulant treatment,

known local anesthetics and opioid allergy,

infection of the skin at the site of the needle puncture,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector spinae plane block

    Drug

    The procedure will be performed with the patient in the supine position after surgery before extubation. ESPB will be performed. The US probe will be placed longitudinally 2-3 cm lateral to the T2 transverse process. The erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted in a caudo-cranial direction, and then, for correction, 5 ml of saline will be injected deep into the erector spinae muscle fascia. Following confirmation of the correct position of the needle, 30 mL %0.25 bupivacaine will be administered for the block.

  • Serratus posterior superior intercostal plane block

    Drug

    A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the sitting position after surgery before extubation. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.

  • Postoperative analgesia management

    Drug

    Patients will be administered ibuprofen 400 mg 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 a 10 mcg bolus without an infusion dose, a 10-minute lockout time, and a 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group SPSIPB = SPSIPB groupActive comparator 2 interventions
Group B: Group ESPB = ESPB groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Opioid consumption (fentanyl)

The primary aim is to compare postoperative opioid consumption

Time frame
Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours

Secondary outcomes

1

Pain scores (Numerical rating scores-NRS)

The secondary aim is to compare NRS at the postoperative 24 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

Time frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
2

Need for rescue analgesia (meperidine)

The secondary aim is to compare rescue analgesia used in the postoperative 24 h.

Time frame
Postoperative 24 hours period
3

Adverse events

The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use

Time frame
Postoperative 24 hours period

Other outcomes

Sponsors and contacts

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Medipol University

Lead sponsor

Source ClinicalTrials.gov
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