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

NCT06660875 | Recruiting

• 1 other identifier: AEŞH-BADEK-1003-2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Remifantanile conception; Acute pain; Postoperatif pain

Outcome Measures

Primary Outcomes (1)

• Intraoperative remifentanil consumption

  The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded

  During The intraoperatif period

Secondary Outcomes (1)

• Pain scores

  First 24 hours after surgery

Study Arms (2)

Serratus posterior superior intercostal plane block

ACTIVE COMPARATOR

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.

Drug: Serratus posterior superior intercostal plane block

Interscalene brachial plexus block and superficial cervical plexus block

ACTIVE COMPARATOR

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.

Drug: Interscalene brachial plexus block and superficial cervical plexus block

Interventions

Serratus posterior superior intercostal plane block 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.

Serratus posterior superior intercostal plane block

Interscalene brachial plexus block and superficial cervical plexus block 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.

Interscalene brachial plexus block and superficial cervical plexus block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MÜRÜVVET TAŞKIR TURAN, MD

CONTACT

00905065536934; taskirmuruvvet@gmail.com

MUSA ZENGİN, Associate Professor

CONTACT

00905307716235; musazengin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 28, 2024
• Study Start: October 21, 2024
• Primary Completion: October 11, 2025
• Study Completion: October 21, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

TU (1)