Comparison of Postoperative Analgesic Efficacy of SPSIPB and Combination of IBPB and SCPB

NCT ID: NCT06660875

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-10-21

Brief Summary

Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Nerve blocks provide better pain control, opioid consumption in the postoperative period, and consequently have advantages such as fewer side effects and lower risks of pulmonary and cardiac complications. Multimodal analgesia approach is preferred for patients undergoing shoulder arthroscopy. Along with intravenous analgesic agents, peripheral nerve blocks (applied to every suitable and consenting patient) are performed based on patient preference. This study aims to compare the analgesic efficacy in the postoperative period of patients undergoing shoulder arthroscopy with a combination of interscalene brachial plexus block and superficial cervical plexus block with serratus posterior superior intercostal plane block.

Conditions

Shoulder Arthroscopy; İnterscalene Brachial Plexus Block; Superficial Cervical Plexus Block; Serratus Posterior Superior Intercostal Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Serratus posterior superior intercostal plane block

With the patient in the prone position the skin is disinfected .Linear USG probe is placed on the spine of the scapula using an in-plane technique and moved medially. The 3rd rib is identified just on the medial scapular border. After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from top to bottom) under USG guidance, a 22-G X 80-mm block needle is directed caudally and advanced until it contacted the rib. To confirm and obtain a plane between the serratus posterior superior and intercostal muscles, hydrodissection is performed using 2 ml of isotonic solution. After the needle site is confirmed, 30 ml of 0.25% bupivacaine is injected ; the local anesthetic spread is confirmed by USG.

Group Type: ACTIVE_COMPARATOR

Serratus posterior superior intercostal plane block

Intervention Type: DRUG

Serratus posterior superior intercostal plane block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.

Interscalene brachial plexus block and superficial cervical plexus block

İBPB:While the patient is in the supine position, the ultrasound probe is placed on the cricoid cartilage and moved laterally to visualize the trachea, thyroid, carotid artery, internal jugular vein, and sternocleidomastoid muscle. The brachial plexus is identified by directing it posteriorly and laterally between the anterior and middle scalene muscles. After entering between the roots using the in-plane technique and confirming the location with a 2 ml isotonic sodium injection, 20 ml of 0.25% bupivacaine is injected.

SCPB:While the patient is in the supine position, the ultrasound probe is placed at the midpoint of the sternocleidomastoid (SCM) muscle. The cervical plexus is visualized deep to the posterior border of the SCM muscle. The needle is inserted deep to the SCM, directed towards the levator scapula. After confirming the location with a 2 ml isotonic sodium injection, 10 ml of 0.25% bupivacaine is injected.

Group Type: ACTIVE_COMPARATOR

Interscalene brachial plexus block and superficial cervical plexus block

Intervention Type: DRUG

İnterscalene brachial plexus block and superficial cervical plexus block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.

Interventions

Serratus posterior superior intercostal plane block

Serratus posterior superior intercostal plane block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.

Intervention Type: DRUG

Interscalene brachial plexus block and superficial cervical plexus block

İnterscalene brachial plexus block and superficial cervical plexus block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• Body mass index 18 to 30 kg/m2
• Elective shoulder arthroscopy surgery

Exclusion Criteria

• Under 18 and over 65
• ASA score IV and above
• Advanced co-morbidity
• History of bleeding diathesis
• BMI under 18 kg/m2 and over 30 kg/m2
• Patient refusing the procedure
• Patients who have previously undergone shoulder surgery
• Chronic opioid or analgesic use
• Patients who will operate under emergency conditions
• Patients who will not undergo shoulder surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muruvvet Taskir Turan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

MÜRÜVVET TAŞKIR TURAN, MD

Role: CONTACT

taskirmuruvvet@gmail.com

00905065536934

MUSA ZENGİN, Associate Professor

Role: CONTACT

musazengin@gmail.com

00905307716235

Facility Contacts

MÜRÜVVET TAŞKIR TURAN, MD

Role: primary

taskirmuruvvet@gmail.com

00905065536934

MUSA ZENGİN, Associate Professor

Role: backup

musazengin@gmail.com

00905307716235

Other Identifiers

AEŞH-BADEK-1003-2024

Identifier Type: -

Identifier Source: org_study_id