Chronic Pain in Post-Mastectomy Patients; The Difference Between Pectoral Nerve (PECS I-II) and Erector Spinal Plane (ESP) Blocks
NCT ID: NCT06900842
Last Updated: 2025-03-28
Study Results
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Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2024-05-22
2024-09-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Nurefsan Sadikoglu
Specialist in Anesthesiology
Locations
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Hacettepe University Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Breast Cancer Facts \& Figures 2019-2020
Other Identifiers
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2024/09-07 (KA-23086)
Identifier Type: -
Identifier Source: org_study_id
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