Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Pectoral Nerve (PECS II) Block For Pain Control In Breast Surgeries: A Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bedside forced vital capacity at 2 hours after surgery
研究概览
简要总结
The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries.
详细描述
All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Standard basic monitoring will be applied to all patients then after adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.
SPSIP group After induction of anesthesia, patients will be placed in lateral decubitus position, the affected arm will be adducted and medially rotated. Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The structures from superficial to deep are skin, subcutaneous, trapezius, rhomboid, serratus posterior superior and intercostal muscles. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
PECS II group With the patient in supine position, the ipsilateral upper arm will be abducted and externally rotated. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed. Intravenous 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.
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
- Double (Participant, Investigator)
盲法说明
double blinded study
入排标准
- 年龄范围
- 21 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 21 to 70 years.
- •American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.
排除标准
- •Any patient refuses to participate.
- •Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
- •Chronic opioid use.
- •Patients with pulmonary diseases.
- •History of allergy to local anesthetics.
- •Infection at the needle entry point will be excluded.
研究组 & 干预措施
SPSIP Group
Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
干预措施: Serratus posterior superior intercostal plane block (Procedure)
PECS II group
Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
干预措施: PECS II block (Procedure)
结局指标
主要结局
Bedside forced vital capacity at 2 hours after surgery
时间窗: Two hours after surgery
Three measurements were taken and the highest one was recorded
Total morphine consumption
时间窗: first postoperative 24 hour
Total morphine consumption in first postoperative twenty four hour
次要结局
- NRS pain scores for breast when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement(when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour)
- Time to first rescue opioid dose(24 hours after surgery)
- Incidence of chronic pain at 3 and 6 months after surgery(6 months after surgery)
- Block related complications and side effects(24 hours after surgery)
- Axilla NRS pain scores evaluated at the same time points of that for breast pain(24 hours after surgery)
- Bedside forced vital capacity at 6 and 24 hours after surgery(24 hours after surgery)
- NRS when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour(when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour)
研究者
Ahmed Abdel Wahed Ali
lecturer at Anesthesia & Surgical ICU and Pain Medicine
Tanta University
