A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- The primary outcome is to assess the incidence of PMPS 3 months after surgery.
研究概览
简要总结
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
详细描述
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) ¹.
The International Association for Study of Pain (IASP) defines PMPS as chronic pain that persists more than 3 months in the anterior thorax, axilla &/or upper arm ². It is usually neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia, allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is usually of at least moderate intensity and may be either continuous or intermittent pain ³.
The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are believed to be associated with PMPS, including the presence and intensity of postoperative pain, the type of surgery, younger women, prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴.
Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵. Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period, However clinically the role of RA in preventing PMPS is still under investigations ⁶.
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and ≤ 60 years old.
- •Female patients ASA ΙΙ, ΙΙΙ.
- •Female patients scheduled for unilateral breast surgeries.
排除标准
- •Patient refusal.
- •Patients have sepsis
- •Patients known to have allergy against local anesthetics.
- •Patients with prior surgery in areas above or below the clavicle or in the axillary region.
- •Patients with opioid dependence, alcohol or drug abuse.
- •Patient with coagulopathy.
- •Patients with psychiatric illness that prevent them from proper pain perception and assessment.
- •ASA 4 or higher.
研究组 & 干预措施
Paravertebral Block Group
This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block
干预措施: Paravertebral plane block (Procedure)
Erector Spinae Block Group
This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block
干预措施: Erector spinae plane block (Procedure)
Control Group
This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol).
干预措施: Intravenous morphine, ketorlac and paracetamol (Drug)
结局指标
主要结局
The primary outcome is to assess the incidence of PMPS 3 months after surgery.
时间窗: 3 months
* A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI). * Chronic pain is defined by a score of ≥ 3 on the single item (average pain) of the BPI. * The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS.
次要结局
- • The prevalence of PMPS at 6 months.(6 months)
- • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.(48 hours .)
- • PVPB and ESPB related complications.(24 hours)
- • Assessment of acute postoperative pain.(48 hours)