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Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery

ConditionsShoulder PainShoulder Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKahramanmaras Sutcu Imam University

About this trial

Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use.

Serratus posterior superior interfascial plane block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. It has been reported that SPSIPB provides effective shoulder analgesia.

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

  • SPSIPB 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 lateral decubitus position. 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 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group SPSIPB = SPSIPB groupActive comparator 2 interventions
Group B: Group ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption (Fentanyl PCA)

The primary aim is to compare postoperative opioid consumption from the PCA device.

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

Secondary outcomes

1

Pain scores (Numerical rating scale-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

Click on the lead sponsor to view all of their trials.

Kahramanmaras Sutcu Imam University

Lead sponsor

Source ClinicalTrials.gov
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