Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ISBPB

NCT06626191 | Completed

• 1 other identifier: AEŞH-EK1-2024-0073
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder arthroscopy is one of the common surgical procedures performed today. After shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly. Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications. In this study; it was aimed to compare the analgesic effectiveness of interscalene brachial plexus block and serratus posterior superior intercostal plane block, with each other and with the control group in the postoperative period in patients who underwent shoulder arthroscopy.

Conditions

Peripheral Nerve Block; Pain Management; Shoulder Arthroscopy

Keywords

Shoulder Arthroscopy; Interscalene Brachial Plexus Block; Serratus Posterior Superior Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.

  24 hours after surgery

Secondary Outcomes (2)

• Intraoperative remifentanil consumption Intraoperative opioid consumption

  Intraoperative period

• Postoperative Tramadol Consumption

  24 hours after surgery

Study Arms (3)

Interscalene brachial plexus block

ACTIVE COMPARATOR

After the patients are monitored and in the supine position, after appropriate field sterilization, interscalene brachial plexus block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.

Procedure: Interscalene brachial plexus block

Serratus posterior superior intercostal plane block

ACTIVE COMPARATOR

After the patients are monitored and in the sitting position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.

Procedure: Serratus posterior superior intercostal plane block

Group without peripheral nerve block

ACTIVE COMPARATOR

After the patients are monitored, they will be operated under general anesthesia without peripheral nerve block and intraoperative intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.

Procedure: Group without peripheral nerve block

Interventions

Interscalene brachial plexus block PROCEDURE

Interscalene brachial plexus block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.

Interscalene brachial plexus block

Serratus posterior superior intercostal plane block PROCEDURE

Patients will undergo serratus posterior superior intercostal plane block using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.

Serratus posterior superior intercostal plane block

Group without peripheral nerve block PROCEDURE

In the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.

Group without peripheral nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• American Society of Anesthesiologists (ASA) score I-II-III
• Body Mass Index (BMI) between 18-30 kg/m2

You may not qualify if:

• Patients under 18 and over 80 years of age
• ASA score IV and above
• Patients with a history of bleeding diathesis
• BMI below 18 or above 30 kg/m2

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

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 İnvestigator

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 8, 2024
• Primary Completion: January 6, 2026
• Study Completion: January 14, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

TU (1)