Comparison of Erector Spinae Plane Block and Serratus Anterior Plane Block for Post operative analgesia in Pediatric Throacoscopic surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Comparison of postoperative pain intensity between the ESPB and SAPB groups, specifically measured using the FLACC score at the 3 hour mark post surgery.
研究概览
简要总结
This prospective, randomized, double-blinded controlled trial, titled Comparison of Erector Spinae Plane Block and Serratus Anterior Plane Block for Postoperative Analgesia in Pediatric Thoracoscopic Surgeries, A Randomized Trial, aims to evaluate optimal regional analgesic strategies for children undergoing thoracoscopic surgery at AIIMS, New Delhi. Recognizing that even minimally invasive procedures can cause significant postoperative pain, and considering the limitations of traditional blocks in pediatrics, this study compares two ultrasound-guided interfascial plane blocks, the Erector Spinae Plane Block and the Serratus Anterior Plane Block. The core objective is to assess their comparative analgesic efficacy and safety, hypothesizing that ESPB will demonstrate non-inferior analgesic efficacy to SAPB in this patient population.
Following Institutional Ethics Committee approval and informed parental consent, 58 pediatric patients, aged 2 months to 10 years, ASA I-III scheduled for elective thoracoscopic surgery will be randomized to receive either ESPB or SAPB. The ESPB group will receive an ultrasound-guided block at the T5 level with 0.5 mL/kg of 0.25% ropivacaine plus clonidine 1 mcg/kg, while the SAPB group will receive an ultrasound-guided block at the 5th rib midaxillary line with a similar local anesthetic solution. Both blocks are administered post-induction of standardized general anesthesia, with the patient, parents, outcome assessor, and postoperative care team blinded to the allocated intervention.
The primary endpoint is the comparison of postoperative pain intensity using the FLACC score at 3 hours post-surgery. Key secondary outcomes include total intraoperative and 24-hour postoperative fentanyl consumption, FLACC scores at multiple other time points, time to first rescue analgesia, parental satisfaction, early functional recovery, salivary cortisol levels as a stress biomarker, and the incidence of adverse events or block-related complications. The findings are anticipated to provide robust evidence to inform clinical decision-making for postoperative pain management in pediatric thoracoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 2 months to 10 years
- •ASA Physical status I-III
- •Scheduled for thoracoscopic surgery.
排除标准
- •Known allergy or hypersensitivity to local anesthetics such as ropivacaine
- •Coagulopathy or bleeding disorders, or if the patient is receiving anticoagulant therapy
- •Infection at the proposed injection site (e.g., local cellulitis or abscess)
- •Pre-existing neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis) or chronic pain conditions that may interfere with pain perception or assessment
- •Developmental delay or cognitive impairment that prevents reliable use of the FLACC pain scale
- •Refusal to participate by parent or legal guardian or withdrawal of consent at any point
- •Requirement for postoperative mechanical ventilation, either planned or anticipated intraoperatively
- •Conversion to thoracotomy.
结局指标
主要结局
Comparison of postoperative pain intensity between the ESPB and SAPB groups, specifically measured using the FLACC score at the 3 hour mark post surgery.
时间窗: at 3 hour mark after surgery
次要结局
- Compare the total intraoperative and postoperative fentanyl consumption between the Erector Spinae Plane Block (ESPB) group and the Serratus Anterior Plane Block (SAPB) group.(During surgery and till 24 hrs post surgery)
- Compare postoperative pain intensity using the FLACC (Face, Legs, Activity, Cry, Consolability) score at 1, 6, 12 and 24 hours postoperatively between the two groups.(At 1, 6, 12, 24 hours postoperatively)
- Compare the time interval from the end of surgery to the first administration of rescue analgesia between the two groups.(Until 24 hours postoperatively)
- Assess parental satisfaction with the allocated postoperative pain management regimen using a 5-point Likert scale.(During 24 hour postoperative period)
- Assess early functional recovery using caregiver-reported outcomes, potentially including parameters like mobility, feeding, and sleep patterns.(Boretsky recover Bingo card(During 24 hour postoperative period)
- Compare salivary cortisol levels, as a physiological marker of stress, at baseline, at one hour, and 24 hours postoperatively between the two groups.(Baseline, at one hour and 24 hours post surgery)
- Evaluate and compare the incidence of adverse events, including postoperative nausea and vomiting (PONV), sedation, hypotension, and any complications directly related to the nerve block procedure (e.g., hematoma, infection, visceral injury), between the two groups.(During surgery and till 24 hour post operative period)
研究者
Anjith V
All India Institute of Medical Sciences