Comparison of ESP and SPSIP Blocks in Breast Surgery

NCT06611644 | Completed

• 1 other identifier: COMU-SBF-ME-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Effective pain control is crucial for accelerating recovery, reducing the risk of complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the administration of local anesthetics into fascial plane spaces to achieve peripheral nerve blockade and control pain. This study will evaluate the effectiveness of these blocks in terms of pain scores, opioid consumption, and overall patient satisfaction to determine the optimal approach for postoperative pain management in breast surgery.

Conditions

Breast Surgery; Macromastia; Mammaplasty; Modified Radical Mastectomy; Mammary Cancer; Breast Implant

Keywords

Pain Management; Regional Anesthesia; Multimodal Treatment; Modified Radical Mastectomy; Mammaplasty; Breast Implants

Outcome Measures

Primary Outcomes (2)

• Postoperative Opioid Consumption

  Postoperative opioid consumption will be monitored using a Patient-Controlled Analgesia (PCA) device, which will be connected to each patient at the end of surgery. The PCA settings will be 2 mg/cc tramadol solution, with no basal infusion, a lockout time of 20 minutes, and a 10 mg bolus dose. The total opioid (tramadol, Unit: miligram) consumption over 24 hours will be recorded, including the number of times the patient required analgesia and the number of bolus doses administered by the device.

  24 hours

• Numeric Rating Scale (NRS)

  Pain intensity will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). NRS scores will be recorded to evaluate postoperative pain levels in each group at specific intervals.

  24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)

Secondary Outcomes (3)

• Verbal Descriptive Nausea and Vomiting Scale

  24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)

• Patient Satisfaction

  24 hours postoperatively

• Length of Hospital Stay

  Up to 1 week postoperatively (measured in hours)

Study Arms (3)

Erector Spinae Plane (ESP) block group

ACTIVE COMPARATOR

This group will include patients who undergo the Erector Spinae Plane (ESP) block. The ESP block will be performed under ultrasound guidance, with a needle placed on the transverse process of the vertebra to inject local anesthetic into the erector spinae muscle.

Other: Erector Spinae Plane Block

Serratus Posterior Superior Intercostal Plane (SPSIP) block

ACTIVE COMPARATOR

This group will include patients who undergo the Serratus Posterior Superior Intercostal Plane (SPSIP) block. The SPSIP block will be performed under ultrasound guidance, injecting local anesthetic into the plane between the serratus posterior superior muscle and the intercostal muscles.

Other: SPSIPB blcok

Control Group

OTHER

Patients in this group will receive standard postoperative pain management. This management will be provided through systemic analgesics (e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and opioids if necessary) based on the patient's pain level during the postoperative period. This group will consist of patients who do not receive regional blocks, and pain management will be conducted according to the standard procedure of the surgery.

Other: Control

Interventions

Erector Spinae Plane Block OTHER

Patients in this group will receive an Erector Spinae Plane (ESP) block in addition to standard postoperative care. The ESP block will be performed under ultrasound guidance. A needle will be advanced in-plane or out-of-plane, targeting the lateral aspect of the T6 transverse process. Local anesthetic (20 to 30 ml) will be injected into the fascial plane between the erector spinae muscle and the transverse process. This block is intended to provide postoperative analgesia by blocking the transmission of pain through the thoracic spinal nerves.

Erector Spinae Plane (ESP) block group

SPSIPB blcok OTHER

Patients in this group will receive a Serratus Posterior Superior Intercostal Plane (SPSIP) block along with standard postoperative care. The SPSIP block will be performed under ultrasound guidance, where the needle is advanced between the second and third ribs towards the medial aspect of the scapula. Local anesthetic 20 to 30 ml) will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles after confirming needle placement with hydrodissection using 1-2 ml of saline. This block is intended to provide broad analgesia across the upper thoracic dermatomes, from C3 to T7, to control postoperative pain.

Serratus Posterior Superior Intercostal Plane (SPSIP) block

Control OTHER

Patients in the control group will receive standard postoperative pain management without any regional block intervention. This will include the administration of systemic analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs). Opioid analgesics will be administered as needed based on the patient's pain level. Pain management will be conducted according to the standard protocol followed for breast surgery patients.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only individuals as female will be eligible to participate in this study, as the focus is on breast surgeries, which are performed on female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Scheduled for breast surgery (Modified Radical Mastectomy with or without axillary lymph node dissection, Mastopexy, Reduction Mammoplasty).
• Preoperative anesthesia risk classified as ASA I-III according to the American -Society of Anesthesiologists (ASA) classification.
• Patients who provide informed consent for participation in the study.

You may not qualify if:

• History of coagulation disorders.
• Patients using aspirin or medically prescribed anticoagulants.
• Patients with severe systemic diseases (ASA IV).
• Patients undergoing emergency surgery.
• Patients younger than 18 or older than 65 years.
• Patients who do not develop adequate sensory block after the procedure.
• Presence of infection at the block site.
• Patients with thoracic deformities.
• Patients who decline to participate in the study.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, 17020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gigantomastia; Breast Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted in a double-blind design. Neither the patients nor the researchers assessing pain management will know which treatment has been applied. The anesthesia team, present in the operating room and responsible for administering the blocks, will be aware of the group assignments, but the research team responsible for postoperative evaluations will not have access to this information. The operating room coordinator will assign each patient to the appropriate group according to a randomization list and will only share this information with the anesthesia team. The research team evaluating postoperative pain scores and collecting data will do so without knowledge of the patients\' treatment group, ensuring objectivity in the assessments through blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study consists of three groups: a Control Group receiving standard postoperative pain management, an ESP Block Group receiving an Erector Spinae Plane (ESP) block, and an SPSIP Block Group receiving a Serratus Posterior Superior Intercostal Plane (SPSIP) block, all aimed at comparing the efficacy of these methods in managing postoperative pain.

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: July 6, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 16, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)