Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies

NCT06423677 | Completed

• 1 other identifier: Serratus Posterior Superior
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner. Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.

Conditions

Pain, Postoperative; Shoulder Pain; Block

Outcome Measures

Primary Outcomes (2)

• visual analog scale score

  Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

  0, 1, 6, 12, and 24 hours

• opioid consumption

  Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

  0, 1, 6, 12, and 24 hours

Study Arms (2)

serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

ACTIVE COMPARATOR

serratus posterior superior intercostal plane block will be administered to these group. after the extubation intravenous patient controlled analgesia (PCA) will also be administered to patients.

Procedure: Serratus Posterior Superior Intercostal Plane Block; Device: patient controlled analgesia

intravenous patient controlled analgesia

ACTIVE COMPARATOR

After the extubation, only intravenous patient controlled analgesia (PCA) will be administered to patients.

Device: patient controlled analgesia

Interventions

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

The Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner.

serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

patient controlled analgesia DEVICE

intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours

intravenous patient controlled analgesia; serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

Eligibility Criteria

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

You may qualify if:

• Obtaining consent from the patient and their relative
• ASA score of I-II
• No bleeding diathesis
• No history of anticoagulant use
• No history of neuropathic diseases such as Diabetes Mellitus
• Patients aged 18-65 years undergoing shoulder arthroscopy surgery

You may not qualify if:

• Lack of consent from the patient or their relative
• Patients with an ASA score of III or above
• Patients with a history of bleeding diathesis
• Conditions where regional anesthesia is contraindicated
• Patients with a history of neuropathic diseases
• Patients under 18 years or over 65 years of age
• Patients with a history of allergies to the aforementioned medications
• Patients with an infection at the site where the block will be administered

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain; Bites and Stings

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Engin ihsan Turan

  Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: June 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

TU (1)