Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy

Официальное название

Analgesic Efficacy Comparison of Combined PECS II and Superficial Parasternal Intercostal Plane (PIP) Block Versus Thoracic Paravertebral Block Post-Mastectomy: An Assessment of Pain Severity, Analgesia Duration, and Recovery Quality

Обзор

Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall. The purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND). Participants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.

Подробное описание

Breast cancer surgery, particularly mastectomy with or without axillary lymph node dissection (ALND), is associated with significant acute postoperative pain. Inadequate pain control in the immediate postoperative period can prolong hospital stay, delay functional recovery, and increase the risk of persistent post-mastectomy pain syndrome. While Thoracic Paravertebral Block (TPVB) has long been considered a gold standard for unilateral thoracic surgery analgesia, its technical difficulty and risk of serious complications such as pneumothorax and systemic toxicity prompt the search for safer alternatives.

The PECS II block targets the lateral and medial pectoral nerves, intercostobrachial nerve, and lateral cutaneous branches of intercostal nerves T2-T6. However, it may not consistently cover the anterior cutaneous branches near the sternum. Combining the PECS II block with a Superficial Parasternal Intercostal Plane (PIP) block aims to provide complete coverage of both the lateral and anterior thoracic wall, potentially offering comparable or superior analgesia to TPVB with a lower complication profile.

In this single-blind randomized controlled trial conducted at Dharmais Cancer Hospital, eligible female patients scheduled for mastectomy are randomized into two parallel groups:

1. Intervention Group: Receives an ultrasound-guided combination of PECS II block (25 mL 0.25% Bupivacaine) and Superficial PIP block (10 mL 0.25% Bupivacaine) prior to surgical incision. 2. Control Group: Receives an ultrasound-guided Thoracic Paravertebral Block at T4 and T6 levels (10 mL total of 0.25% Bupivacaine).

Standardized general anesthesia and intraoperative monitoring (including hemodynamics and qNOX index for depth of analgesia) are maintained for all subjects. Postoperatively, patients receive standard oral paracetamol and IV ketorolac, supplemented with IV Morphine via a Patient-Controlled Analgesia (PCA) device.

Study endpoints include Numeric Rating Scale (NRS) pain scores evaluated at rest and movement at 0, 6, 12, and 24 hours post-surgery; quality of recovery measured via the QoR-15 questionnaire at 24 hours; time to first PCA activation (duration of analgesia); total 24-hour morphine consumption; and monitoring for complications including local anesthetic systemic toxicity (LAST), hematoma, and pneumothorax.

Вмешательства

• Процедура Combined PECS II and Superficial PIP Block
  Ultrasound-guided regional nerve block administration consisting of PECS II block (25 mL 0.25% Bupivacaine) and superficial PIP block (10 mL 0.25% Bupivacaine) post-induction of general anesthesia prior to surgical incision.
• Процедура Thoracic paravertebral block (TPVB)
  Ultrasound-guided regional nerve block administration consisting of TPVB with 0.25% Bupivacaine (5 mL at T4 level and 5 mL at T6 level) post-induction of general anesthesia prior to surgical incision.

Первичные конечные точки

• Postoperative Quality of Recovery Score (QoR-15) [Срок оценки: 24 hours postoperatively]
• Postoperative Pain Severity (NRS) [Срок оценки: Postoperative hours 0, 6, 12, and 24]
• Duration of Analgesia [Срок оценки: Up to 24 hours postoperatively]

Вторичные конечные точки (2)

• Regional Block Procedure Execution Time [Срок оценки: Intraoperative (during regional block administration)]
• Block-Related Complications [Срок оценки: Intraoperative through 24 hours postoperatively]

Критерии участия

Критерии включения

• Female patients aged 18 to 60 years.
• Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \[ALND\]).
• American Society of Anesthesiologists (ASA) physical status I to III.
• Provided signed written informed consent to participate in the study.

Критерии исключения

• Patient refusal to participate in the study.
• Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine).
• Coagulation disorders or coagulopathy.
• Mastectomy procedure with immediate breast reconstruction.
• Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl).
• Cognitive impairment or inability to comprehend the pain assessment scale (NRS).
• Pregnancy.
• Active infection at the planned regional block injection site.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Индонезия · 1 центр

• Dharmais National Cancer Center Hospital — Jakarta

Публикации

• Martinez-Vazquez P, Jensen EW. Different perspectives for monitoring nociception during general anesthesia. Korean J Anesthesiol. 2022 Apr;75(2):112-123. doi: 10.4097/kja.22002. Epub 2022 Feb 17. PMID 35172074
• Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30. PMID 31047645
• Barrington MJ, Seah GJ, Gotmaker R, Lim D, Byrne K. Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration. Anesth Analg. 2020 Jun;130(6):1559-1567. doi: 10.1213/ANE.0000000000004371. PMID 31490251
• Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21. PMID 29605019
• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PMID 29397134
• Wessels E, Perrie H, Scribante J, Jooma Z. Quality of recovery in the perioperative setting: A narrative review. J Clin Anesth. 2022 Jun;78:110685. doi: 10.1016/j.jclinane.2022.110685. Epub 2022 Feb 18. PMID 35190342
• Teng WN, Lin YS, Sung CS, Tseng LM, Chang WK, Ting CK. Analgesia-nociception index accurately predicts inadequate pectoralis muscle fascia block (PECS) in patients undergoing breast surgery: A prospective observational study. J Formos Med Assoc. 2025 Jan;124(1):38-43. doi: 10.1016/j.jfma.2024.02.019. Epub 2024 Mar 5. PMID 38448346

Идентификаторы

NCT: NCT07738770 · DP.04.03/12.04/122/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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