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Breast Cancer SurgeryNCT06900842

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

An observational study of Breast Cancer Surgery and Postoperative Pain, Acute, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Type of treatment
Injection or infusion
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 May 2024to 20 Sep 2024
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University Hospital

    Ankara, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
breast cancer, Postoperative Pain, Chronic Pain, PECS I-II Block, Erector Spinae Plane Block, ESP Block, Chronic Pain Prevention, Quality of Life
Medical subject headings
Pain, Postoperative, Bites and Stings, Neuralgia, Breast Neoplasms, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06900842
Study groupRoleWhat they receive
PECS I-II Block GroupThis 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 GroupThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months after surgery

Secondary outcomes (5)
  1. Postoperative Acute Pain Scores (NRS)

    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.

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

  2. Total Postoperative Opioid Consumption (Morphine, mg)

    The total amount of intravenous morphine consumed via patient-controlled analgesia (PCA) pump will be recorded and compared between groups to assess analgesic requirements.

    Measured: Within 24 hours after surgery

  3. Time to First Analgesic Requirement

    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.

    Measured: Within 24 hours after surgery

  4. Postoperative Quality of Life (SF-12 Score)

    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.

    Measured: 3 months after surgery

  5. Presence of Neuropathic Pain (DN4 Score > 4)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start22 May 2024
  3. Primary completion20 Sep 2024
  4. Study completion20 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900842
Sponsor's protocol ID
2024/09-07 (KA-23086)
Status last verified
Mar 2025
First submitted
22 Mar 2025
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Documents will be shared upon request

Publications

  • Banerjee S, Goswami R. GST profile expression study in some selected plants: in silico approach. Mol Cell Biochem. 2010 Mar;336(1-2):109-26. doi: 10.1007/s11010-010-0384-y. Epub 2010 Feb 5.

    PubMed 20135200
  • Carpenter JS, Andrykowski MA, Sloan P, Cunningham L, Cordova MJ, Studts JL, McGrath PC, Sloan D, Kenady DE. Postmastectomy/postlumpectomy pain in breast cancer survivors. J Clin Epidemiol. 1998 Dec;51(12):1285-92. doi: 10.1016/s0895-4356(98)00121-8.

    PubMed 10086821
  • Meijuan Y, Zhiyou P, Yuwen T, Ying F, Xinzhong C. A retrospective study of postmastectomy pain syndrome: incidence, characteristics, risk factors, and influence on quality of life. ScientificWorldJournal. 2013 Nov 27;2013:159732. doi: 10.1155/2013/159732. eCollection 2013.

    PubMed 24379736
  • Alves Nogueira Fabro E, Bergmann A, do Amaral E Silva B, Padula Ribeiro AC, de Souza Abrahao K, da Costa Leite Ferreira MG, de Almeida Dias R, Santos Thuler LC. Post-mastectomy pain syndrome: incidence and risks. Breast. 2012 Jun;21(3):321-5. doi: 10.1016/j.breast.2012.01.019. Epub 2012 Feb 27.

    PubMed 22377590
  • Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

    PubMed 12855309
  • DeSantis CE, Ma J, Goding Sauer A, Newman LA, Jemal A. Breast cancer statistics, 2017, racial disparity in mortality by state. CA Cancer J Clin. 2017 Nov;67(6):439-448. doi: 10.3322/caac.21412. Epub 2017 Oct 3.

    PubMed 28972651
  • Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

    PubMed 19903919
  • Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.

    PubMed 15655557
  • Hanley MA, Jensen MP, Smith DG, Ehde DM, Edwards WT, Robinson LR. Preamputation pain and acute pain predict chronic pain after lower extremity amputation. J Pain. 2007 Feb;8(2):102-9. doi: 10.1016/j.jpain.2006.06.004. Epub 2006 Sep 1.

    PubMed 16949876
  • Tasmuth T, Kataja M, Blomqvist C, von Smitten K, Kalso E. Treatment-related factors predisposing to chronic pain in patients with breast cancer--a multivariate approach. Acta Oncol. 1997;36(6):625-30. doi: 10.3109/02841869709001326.

    PubMed 9408154
  • Miguel R, Kuhn AM, Shons AR, Dyches P, Ebert MD, Peltz ES, Nguyen K, Cox CE. The effect of sentinel node selective axillary lymphadenectomy on the incidence of postmastectomy pain syndrome. Cancer Control. 2001 Sep-Oct;8(5):427-30. doi: 10.1177/107327480100800506.

    PubMed 11579339
  • Steegers MA, Wolters B, Evers AW, Strobbe L, Wilder-Smith OH. Effect of axillary lymph node dissection on prevalence and intensity of chronic and phantom pain after breast cancer surgery. J Pain. 2008 Sep;9(9):813-22. doi: 10.1016/j.jpain.2008.04.001. Epub 2008 Jun 30.

    PubMed 18585963
  • Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

    PubMed 27543533
  • Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb;62(2):148-150. doi: 10.4103/ija.IJA_726_17. No abstract available.

    PubMed 29491525
  • Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.

    PubMed 29102405

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Surgery and Postoperative Pain, Acute, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Chronic Postoperative Pain (NRS ≥1) (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06900842, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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