Efficacy of the Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy as a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest.
研究概览
简要总结
Several studies proved that the serratus anterior plane block(SAPB) offer analgesia not inferior or as effective to opioids which is mainstay of analgesia (chai et al., 2023).
In this study we will compare the analgesic effect of the serratus anterior plane block versus a new paraspinal technique block which is the midpoint transverse process to pleura (MTP) block for postoperative analgesia after modefied radical mastectomy.
详细描述
Breast cancer is the most common cancer in women both in the developed and less developed world. In 2012, it represented about 12 percent of all new cancer cases and 25 percent of all cancers in women (Jain et al., 2020).
Surgery is one of the mainstays of treatment, and a procedure called modified radical mastectomy (MRM) is now a standard surgical treatment for early stage breast cancers.These procedures cause significant acute pain and may progress to chronic pain states in 25-60% of cases (Andersen and Kehlet, 2011).
Though various risk factors have been suggested, inappropriate acute postoperative pain management has been associated with the development of chronic post mastectomy pain, a complex post-surgical pain syndrome that may occur following any type of breast surgery (Macrea, 2001). The traditional opioid based analgesia remains the mainstay, however. Different techniques including regional local anaesthetic infiltration, paravertebral and neuroaxial analgesia, anti_neuropathic analgesics and NMDA antagonists have all been used either singly or in combination, (Macrea, 2001). Post operative pain is usually acute nociceptive pain, it occurs as normal response to noxious insult or injury (Dworkin et al., 2007) .
Inadequately controlled pain negatively affects quality of life, functional recovery and increase the risk for post-surgical complications (Apfelbaum, 2003).
After the application of ultrasound in anaesthetic practice,several blocks have been described recently,Serratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs (Chin et al., 2021), in which the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T2-T9),long thoracic nerve,and the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles (Blanco et al., 2013).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients undergoing unilateral Modified Radical Mastectomy. Physical status: ASA grades I and II. Age between 35 and 60 years old.
排除标准
- •Known Allergy to one of the study drugs. Asthmatic patients. Patients undergoing bilateral Modified Radical Mastectomy. Patients refusal of procedure or participation in the study. ASA classes III or above. Local skin infection at the site of the block. Pregnant Patients. Other malignancy. History or evidence of coagulopathy. History of use of anti coagulant or anti platelet therapy. Body mass index ≥40 kg/m2.
研究组 & 干预措施
Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15)
Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15):
The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) (Blanco et al., 2013). A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection (Lin J et al., 2020).
干预措施: Serratus Anterior Plane Block (SAPB) (Procedure)
GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15)
GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15):
In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space (Chin et al., 2021), a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection (Syal et al., 2020; Pusch et al., 2000).
干预措施: Midpoint transverse process to pleura (MTP) block (Procedure)
结局指标
主要结局
the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest.
时间窗: 24 hours post- operative
the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest. If no response within 1 hour pethidine 50mg IM will be given. If NRS pain score is ≥4 at rest after 2 hours another dose of pethidine 25mg IM will be given.
次要结局
- The total number of doses of the rescue analgesia that will be received in the 24 hours postoperatively if the NRS pain score at rest ≥4(24 hours post- operative)
研究者
Alaa Ashraf Hassan Abd Elsalam
Dr
Ain Shams University