Ultrasound-guided Serratus Anterior Plane Block Versus Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in in Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual analogue score (VAS) for pain assessment at 6 hour postoperative
研究概览
简要总结
Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either serratus anterior plane block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to serratus anterior plane block as a promising effective alternative for analgesia for arthroscopic shoulder surgeries with fewer side effects. It is suggested that the PENG block can be safely applied for analgesia.
详细描述
Multimodal pain management is recommended for early postoperative pain control in arthroscopic shoulder surgery. Regional anesthesia is preferred in shoulder surgery as an effective means of providing anesthesia and postoperative analgesia.Commonly used techniques for shoulder surgery include interscalene brachial plexus (ISB) blocks, continuous ISB (CISB) blocks, suprascapular nerve blocks (SSB), supraclavicular nerve blocks (SCB), local infiltration (LI), and ISB with adjuvants. Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery.Relevant studies have found that ultrasound-guided serratus anterior plane block(SAPB) can achieve good anterior lateral chest wall analgesia by injecting local anesthetics into the anterior saw muscle and blocking the lateral cutaneous branch of intercostal nerve which has a significant analgesic effect.The pericapsular nerve group (PENG) block may be safely applied for both partial anesthesia and analgesia in selected shoulder surgery cases. It did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. PENG block has been studied extensively in hip surgeries but its place in shoulder surgeries is not yet clear. Therefore, this study will be conducted to compare efficacy of ultrasound guided serratus anterior plane block with PENG block for postoperative analgesia in patients undergoing arthroscopic shoulder surgeries.
The aim of this study:
The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either serratus anterior plane block versus PENG block comparing and evaluating the differences between the two techniques.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with mean VAS score at 6 h postoperative as the primary outcome. Using the results published by Zhu H, et al 2022 with mean VAS score at 6 h postoperative in serratus group was (1.85 ± 0.59 ) Using a two-sided two-sample unequal-variance t-test., sample size of 44 patients is needed to achieve 90% power to detect 30 % difference in at 6 h postoperative. Using a two-sided hypothesis test with a significance level of 0.05. A10% drop out is considered, so a total of 50 patients will be enrolled (25 in each group) in this study
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, Outcomes Assessor)
盲法说明
The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) 1 or 2 patients.
- •Scheduled for elective unilateral shoulder arthroscopy.
排除标准
- •Patient's refusal.
- •Altered mental status or un-cooperative patients.
- •History of known sensitivity to the used anesthetics.
- •Bleeding or coagulation diathesis.
- •Infection or redness at the injection site.
- •Significant cardiac dysfunction, hepatic, or renal impairment.
研究组 & 干预措施
Group A (SAPB)
Ultrasound-guided SAPB will be applied while the patient is in the supine position.
干预措施: Serratus anterior plane block (Procedure)
Group B (PENG block)
Ultrasound-guided PENG block will be performed under strict aseptic precautions and patient's arm will be placed in external rotation and abducted at 45 degrees
干预措施: PENG block (Procedure)
结局指标
主要结局
Visual analogue score (VAS) for pain assessment at 6 hour postoperative
时间窗: at 6 hour after the procedure
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed 6 hour after the procedure.
次要结局
- First analgesic request(Up to 24 hours after the procedure)
- Heart rate (HR)(During the procedure)
- Mean arterial blood pressure (MAP)(During the procedure)
- Adverse effects(Up to 24 hours after the procedure)
- Total analgesic requirements of fentanyl(Up to 24 hours after the procedure)
- Visual analogue score (VAS) for pain assessment(Up to 24 hours after the procedure)
研究者
Amany Hazem abdelmaksood EL-deeb
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University