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

NCT ID: NCT06789146

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2026-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Mastectomy Peripheral Nerve Block Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Serratus posterior superior intercostal plane block

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.

Group Type ACTIVE_COMPARATOR

Serratus posterior superior intercostal plane block

Intervention Type 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.

Thoracic Paravertebral Block

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.

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type 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.

Interventions

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Serratus posterior superior intercostal plane block

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.

Intervention Type PROCEDURE

Thoracic Paravertebral Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Atakan Sezgi

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Atakan Sezgi, MD

Role: CONTACT

00905323327000

Mustafa Sırrı Kotanoğlu, Associate Professor

Role: CONTACT

00905322514979

Facility Contacts

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Atakan Sezgi, MD

Role: primary

00905323327000

Mustafa Sırrı Kotanoğlu, Associate Professor

Role: backup

00905322514979

Other Identifiers

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AEŞH-EK-2025-07

Identifier Type: -

Identifier Source: org_study_id

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