Clinical trial NCT06900842: Chronic Pain in Post-Mastectomy Patients; The Difference Between Pectoral Nerve (PECS I-II) and Erector Spinal Plane (ESP) Blocks
Official title: Chronic Pain in Mastectomy Patients; The Difference Between Pectoral Nerve Block (PECS I-II) and Erector Spinal Plane (ESP) Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Despite advancements in breast cancer treatment, chronic postoperative pain-known as post-mastectomy pain syndrome (PMPS)-remains a common complication, with reported rates between 40-50%. It is typically neuropathic in nature and linked to factors such as axillary lymph node dissection, radiotherapy, and high levels of acute postoperative pain. Younger patients are at higher risk, and early neuropathic symptoms may predict long-term pain.

Regional anesthesia techniques, including PECS and erector spinae plane (ESP) blocks, are widely used to improve perioperative pain control and potentially reduce the incidence of chronic pain. These techniques are considered effective and low-risk adjuncts to general anesthesia.

This prospective observational study compares the impact of PECS I-II and ESP blocks on chronic pain development in patients undergoing modified radical mastectomy (MRM). The primary outcome is the incidence of pain at 3 months postoperatively (NRS ≥1). Secondary outcomes include acute pain scores, intraoperative fentanyl use, postoperative morphine requirements, and time to first analgesic. The study also explores associations between chronic pain and variables such as lymph node dissection, radiotherapy.

Findings aim to guide clinical practice in selecting regional anesthesia techniques that provide both immediate and long-term pain relief.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Chronic Postoperative Pain (NRS ≥1)
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Postoperative Acute Pain Scores (NRS)
timeFrame: At 20 minutes, 6 hours, and 24 hours after surgery
measure: Total Postoperative Opioid Consumption (Morphine, mg)
timeFrame: Within 24 hours after surgery
measure: Time to First Analgesic Requirement
timeFrame: Within 24 hours after surgery
measure: Postoperative Quality of Life (SF-12 Score)
timeFrame: 3 months after surgery
measure: Presence of Neuropathic Pain (DN4 Score > 4)
timeFrame: At 20 minutes, 6 hours, 24 hours, and 3 months after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
Study officials:
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