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

March 22, 2025 updated by: Nurefsan Sadikoglu, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Hacettepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Chronic Postoperative Pain (NRS ≥1)
Time Frame: 3 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Acute Pain Scores (NRS)
Time Frame: At 20 minutes, 6 hours, and 24 hours after surgery
Pain intensity will be measured using the Numeric Rating Scale (0-10). Scores will be compared between the PECS and ESP groups to evaluate differences in early postoperative pain control.
At 20 minutes, 6 hours, and 24 hours after surgery
Total Postoperative Opioid Consumption (Morphine, mg)
Time Frame: Within 24 hours after surgery
The total amount of intravenous morphine consumed via patient-controlled analgesia (PCA) pump will be recorded and compared between groups to assess analgesic requirements.
Within 24 hours after surgery
Time to First Analgesic Requirement
Time Frame: Within 24 hours after surgery
The time interval from the end of surgery to the patient's first request for opioid analgesia will be recorded in minutes. This outcome reflects the duration of initial analgesia provided by the block.
Within 24 hours after surgery
Postoperative Quality of Life (SF-12 Score)
Time Frame: 3 months after surgery
The SF-12 Health Survey will be used to assess the physical and mental components of quality of life. Results will be compared between groups and correlated with chronic pain presence.
3 months after surgery
Presence of Neuropathic Pain (DN4 Score > 4)
Time Frame: At 20 minutes, 6 hours, 24 hours, and 3 months after surgery
In patients with NRS > 0, the DN4 (Douleur Neuropathic 4) questionnaire will be used to assess the presence of neuropathic pain. Scores > 4 indicate neuropathic pain.
At 20 minutes, 6 hours, 24 hours, and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/09-07 (KA-23086)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Documents will be shared upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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