Comparative Efficacy of Modified PENG Block Combined With Suprascapular Nerve Block Versus Interscalene Block for Bankart Repair and the Latarjet Surgery : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Score at Rest at 24 Hours Postoperatively
研究概览
简要总结
This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity. This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity.
详细描述
Shoulder stabilization procedures such as Bankart repair and the Latarjet procedure are associated with significant postoperative pain. The interscalene brachial plexus block is considered the standard regional anesthetic technique but is associated with complications including phrenic nerve paralysis and motor weakness. This study evaluates whether a Modified PENG Block combined with Suprascapular Nerve Block can provide comparable postoperative analgesia while reducing block-related complications. This is a prospective, single-center, randomized controlled trial involving 70 ASA I-II adult patients undergoing elective shoulder stabilization surgery at Kasr Al-Ainy Hospital, Cairo University. Participants will be randomly allocated to receive either Modified PENG plus SSNB or ISB before general anesthesia. Pain scores, opioid consumption, time to first rescue analgesia, functional recovery, hemodynamic parameters, and adverse events will be assessed during the first 24 postoperative hours and during follow-up according to the study protocol
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
Participants and outcome assessors will be blinded to treatment allocation. Randomization will be performed using computer-generated random numbers and sealed opaque envelopes. The anesthesiologist performing the block will not be blinded because of the nature of the intervention
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
- •• Male or female patients aged 18 to 65 years.
- •Patients undergoing elective Bankart repair or Latarjet surgery.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Exclusion • Patient refusal.
- •History of allergy to local anesthetics.
- •Chronic opioid use (>3 months).
- •Coagulation disorders.
- •Pre-existing neurological or musculoskeletal disorders.
- •Respiratory compromise (e.g., COPD)
排除标准
- 未提供
研究组 & 干预措施
Modified PENG + Suprascapular Nerve Block (SSNB)
Participants receive an ultrasound-guided Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) before induction of general anesthesia for elective Bankart repair or Latarjet surgery. The Modified PENG Block is performed with 20 mL of 0.25% bupivacaine and the SSNB with 10 mL of 0.25% bupivacaine.
干预措施: • Modified PENG Block combined with Suprascapular Nerve Block (Procedure)
Interscalene Brachial Plexus Block (ISB)
Participants receive an ultrasound-guided Interscalene Brachial Plexus Block (ISB) using 20 mL of 0.25% bupivacaine before induction of general anesthesia for elective Bankart repair or Latarjet surgery
干预措施: • Interscalene Brachial Plexus Block (Procedure)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score at Rest at 24 Hours Postoperatively
时间窗: 24 hours after surgery
Pain intensity at rest will be assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain), 24 hours after surgery. Higher scores indicate worse pain. The primary comparison is between the Modified PENG Block combined with Suprascapular Nerve Block and the Interscalene Brachial Plexus Block.
次要结局
- VAS pain scores(multiple postoperative time points.)
- Total opioid consumption(during the first 24 hours.)
- Visual Analog Scale (VAS) Pain Scores at Postoperative Time Points(multiple postoperative time points.)
研究者
Ahmed hamza ibrahim mohamed
assistant lecture
Cairo University