Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy

NCT06438211 | Completed

• 1 other identifier: 2024/58
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods.

Conditions

Mastectomy; Postoperative Pain; Analgesia

Keywords

serratus anterior plane block; local anesthetic; regional anesthesia; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption

  How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device

  24 hours

Secondary Outcomes (1)

• measuring pain scors

  24 hours

Study Arms (2)

Group I (superficial serratus anterior plane block)

ACTIVE COMPARATOR

Single-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I)

Procedure: superficial or deep serratus anterior plane block for mastectomy

Group II (deep serratus anterior plane block)

ACTIVE COMPARATOR

Single- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I)

Procedure: superficial or deep serratus anterior plane block for mastectomy

Interventions

superficial or deep serratus anterior plane block for mastectomy PROCEDURE

group I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy

Group I (superficial serratus anterior plane block); Group II (deep serratus anterior plane block)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Since breast cancer is much more common in women than men and to ensure homogenization in the study, only female patients will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who will undergo mastectomy surgery
• patients who agreed to participate in the study
• ASA I-II patients

You may not qualify if:

• Patients planned for bilateral breast surgery
• Patients who have had previous breast surgery
• Patients with existing neuropathic pain or receiving treatment for neuropathic pain
• Patients with psychiatric disorders
• Patients with opioid addiction
• Patients allergic to local anesthetics

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

University of Erciyes

Kayseri, Talas, 38100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ayşe Ülgey, MD

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 31, 2024
• Study Start: June 24, 2024
• Primary Completion: February 24, 2025
• Study Completion: May 25, 2025
• Last Updated: August 12, 2025

Record last verified: 2024-05

Locations

TU (1)