Chronic Pain in Post-Mastectomy Patients; The Difference Between Pectoral Nerve (PECS I-II) and Erector Spinal Plane (ESP) Blocks

NCT06900842 | Completed

• 1 other identifier: 2024/09-07 (KA-23086)
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at two types of injections (called PECS and ESP blocks) to see which one works better for reducing pain after breast cancer surgery (mastectomy). The main question it asks is: Which block is better at reducing pain after surgery - PECS or ESP? Women who had this surgery and received one of the two blocks were followed for three months. We looked at how much pain they felt, how much pain medication they needed, and whether they still had pain months later. The results showed that both blocks helped with pain right after surgery. The ESP block lasted a little longer at first, but in general, both groups needed about the same amount of pain medicine. Three months later, about half of the patients still had some pain - especially those who had more extensive surgery or had nerve pain early on. There was no big difference between the two blocks when it came to long-term pain.

Conditions

Breast Cancer Surgery; Postoperative Pain, Acute; Postoperative Pain, Chronic; Post-mastectomy Pain Syndrome; Regional Anesthesia; Pectoral Nerve (PECS) Block; Erector Spine Plane Block; Neuropathic Pain; Mastectomy; Quality of Life (QOL)

Keywords

breast cancer; Postoperative Pain; Chronic Pain; PECS I-II Block; Erector Spinae Plane Block; ESP Block; Chronic Pain Prevention; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Incidence of Chronic Postoperative Pain (NRS ≥1)

  The presence of chronic pain will be evaluated at 3 months postoperatively using the Numeric Rating Scale (NRS). Patients reporting a score of ≥1 will be considered to have chronic postoperative pain. This measure aims to assess the long-term effectiveness of PECS I-II and ESP blocks in reducing chronic pain following mastectomy.

  3 months after surgery

Secondary Outcomes (5)

• Postoperative Acute Pain Scores (NRS)

  At 20 minutes, 6 hours, and 24 hours after surgery

• Total Postoperative Opioid Consumption (Morphine, mg)

  Within 24 hours after surgery

• Time to First Analgesic Requirement

  Within 24 hours after surgery

• Postoperative Quality of Life (SF-12 Score)

  3 months after surgery

• Presence of Neuropathic Pain (DN4 Score > 4)

  At 20 minutes, 6 hours, 24 hours, and 3 months after surgery

Study Arms (2)

PECS I-II Block Group

This group includes patients who received an ultrasound-guided pectoral nerve block (PECS I-II) before undergoing modified radical mastectomy (MRM). PECS I involved the injection of 10 mL of 0.25% bupivacaine between the pectoralis major and minor muscles. PECS II involved the injection of 20 mL of 0.25% bupivacaine between the pectoralis minor and serratus anterior muscles. The block was applied preoperatively at the discretion of the responsible anesthesiologist, independently from the study protocol. Postoperative pain scores, opioid requirements, and chronic pain development were evaluated.

ESP Block Group

This group includes patients who received an ultrasound-guided erector spinae plane (ESP) block before undergoing modified radical mastectomy (MRM). The block was administered at the T4-T5 level, with 20-30 mL of 0.25% bupivacaine injected between the erector spinae muscle and the transverse process. The procedure was performed in the lateral decubitus position and verified via hydrodissection. The decision to perform this block was made independently by the anesthesiologist. Pain scores and analgesic use were tracked to assess the block's effect on acute and chronic postoperative pain.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study did not consider self-identified gender. Only individuals assigned female at birth were included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from female patients aged 18 to 65 years who are scheduled to undergo elective modified radical mastectomy for breast cancer at Hacettepe University Medical Faculty, Department of General Surgery. All participants must be classified as ASA physical status I or II and have received either a PECS I-II or ESP block as part of their routine pain management. Patients with significant comorbidities, pre-existing neurological deficits, or contraindications to regional anesthesia will be excluded.

You may qualify if:

• Scheduled to undergo modified radical mastectomy due to breast cancer
• Decision to perform PECS I-II or ESP block made independently from the study, as part of standard pain management
• Aged between 18 and 65 years
• American Society of Anesthesiologists (ASA) physical status classification I or II
• Female

You may not qualify if:

• Inability to perform the block (e.g., coagulation disorder, allergy to local anesthetics, infection at the injection site)
• Obesity (Body Mass Index \> 35 kg/m²)
• Pre-existing neurological deficits
• Younger than 18 or older than 65 years
• ASA physical status classification III or IV
• Refusal to give informed consent

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital

Ankara, 06230, Turkey (Türkiye)

Location

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Related Links

• Breast Cancer Facts \& Figures 2019-2020

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings; Neuralgia; Breast Neoplasms; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 28, 2025
• Study Start: May 22, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

TU (1)