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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative Quality of Recovery Score (QoR-15)
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
This trial employs a single-blind masking design in which outcome assessors and clinical staff responsible for postoperative care-including recovery room nurses, ward physicians, and research assistants-are blinded to the treatment allocation. The regional block procedures (combined PECS II + PIP block or Thoracic Paravertebral Block) are performed intraoperatively by designated regional anesthesiologists who are not involved in postoperative outcome assessment or data collection, ensuring an unbiased evaluation of pain scores, quality of recovery, and analgesia duration.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •Active infection at the planned regional block injection site.
结局指标
主要结局
Postoperative Quality of Recovery Score (QoR-15)
时间窗: 24 hours postoperatively
Patient-reported quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, where higher scores indicate better overall recovery quality post-surgery.
Postoperative Pain Severity (NRS)
时间窗: Postoperative hours 0, 6, 12, and 24
Pain severity evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements are recorded separately at rest and during active movement (shoulder joint movement / arm elevation).
Duration of Analgesia
时间窗: Up to 24 hours postoperatively
Time elapsed from the completion of surgery (extubation/arrival at recovery room) to the patient's first request or activation of the Patient-Controlled Analgesia (PCA) morphine device. Measured in minutes/hours.
次要结局
- Regional Block Procedure Execution Time(Intraoperative (during regional block administration))
- Block-Related Complications(Intraoperative through 24 hours postoperatively)
研究者
Annisa
Anesthesiologist
Dharmais National Cancer Center Hospital