Comparison of the Postoperative Analgesic Effects of SPSIPB and TPB in Mastectomy Operations

NCT06789146 | Completed

• 1 other identifier: AEŞH-EK-2025-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. Postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome. 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 serratus posterior superior intercostal plane block and thoracic paravertebral block in the postoperative period in patients who underwent mastectomy.

Conditions

Mastectomy; Peripheral Nerve Block; Pain Management

Keywords

Mastectomy; Serratus Posterior Superior Intercostal Plane Block; Thoracic Paravertebral 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.

  On the operation day

Secondary Outcomes (2)

• Intraoperative opioid consumption

  Intraoperative period

• Postoperative Tramadol Consumption

  On the operation day

Study Arms (2)

Serratus posterior superior intercostal plane block

ACTIVE COMPARATOR

After the patients are monitored and in the supine 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

Thoracic Paravertebral Block

ACTIVE COMPARATOR

After the patients are monitored and in the supine position, after appropriate field sterilization, a thoracic paravertebral 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: Thoracic Paravertebral Block

Interventions

Thoracic Paravertebral Block PROCEDURE

Thoracic paravertebral block will be performed on the patients using 30 ml of 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.

Thoracic Paravertebral Block

Serratus posterior superior intercostal plane block PROCEDURE

Serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• 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

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

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: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 12, 2025
• Primary Completion: February 2, 2026
• Study Completion: February 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

TU (1)