Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery

NCT06866054 | Recruiting

• 1 other identifier: E-10840098-202.3.02-744
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Shoulder Pain; Shoulder Injuries

Keywords

Arthroscopic Shoulder Surgery; Postoperative analgesia management; serratus posterior superior intercostal plane block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption (Fentanyl PCA)

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

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

Secondary Outcomes (3)

• Pain scores (Numerical rating scale-NRS)

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

• Need for rescue analgesia (meperidine)

  Postoperative 24 hours period

• Adverse events

  Postoperative 24 hours period

Study Arms (2)

Group SPSIPB = SPSIPB group

ACTIVE COMPARATOR

SPSIPB will be performed

Drug: SPSIPB block; Drug: Postoperative analgesia management

Group Control

OTHER

Conventional analgesia management will be performed

Drug: Postoperative analgesia management

Interventions

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.

Group SPSIPB = SPSIPB group

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.

Group Control; Group SPSIPB = SPSIPB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for arthroscopic shoulder surgery under general anesthesia

You may not qualify if:

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• patients who do not accept the procedure

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Istanbul Medipol University

Istanbul, Bagcilar, 34000, Turkey (Türkiye)

NOT YET RECRUITING

KSU Faculty of Medicine Research Hospital

Kahramanmaraş, 46200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

  PMID: 36883093 BACKGROUND

• Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.

  PMID: 38240640 BACKGROUND

• Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.

  PMID: 37272274 BACKGROUND

• Kulturoglu G, Altinsoy S, Ozguner Y, Cataroglu CK. Novel Serratus Posterior Superior Intercostal Plane Block Provided Satisfactory Analgesia after Breast Cancer Surgery: Two Case Reports. Turk J Anaesthesiol Reanim. 2024 Feb 28;52(1):33-35. doi: 10.4274/TJAR.2024.231431.

  PMID: 38414179 BACKGROUND

• Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.

  PMID: 39101308 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Bora Bilal, Assoc Prof, MD

CONTACT

+905052354430; borabilal@gmail.com

Bahadir Ciftci, Assoc Prof, MD

CONTACT

bciftci@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two models for this study. The first group is the serratus posterior superior intercostal plane block group. The second one is the control group.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 10, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)