Wearable Device to Assess Mobility After Anterior Iliac Grafting Covered With a Regional Block Technique Transversus Abdominis Plane Block: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in Distance
研究概览
简要总结
This study aimed to assess the effect of adding regional technique transversus abdominis plane (TAP) block on postoperative mobilization following anterior iliac bone grafting.
详细描述
Bone grafting or bone harvesting is a procedure to augment deficient bone tissue and is widely used in a number of oral and maxillofacial procedures such as reconstructive surgical interventions.
The role of regional anaesthesia in the prevention of central sensitization occurs when an effective nociceptive regional block prevents pain signals from being conducted from the surgical site to the central nervous system, preventing the development of chronic pain and persistent postsurgical pain (PPP).
The transversus abdominis plane (TAP) block permits a sensory block of the lower 6 thoracic and L1 ventral rami. Imaging studies on cadavers and volunteers have demonstrated the spread of solution in a plane between both muscles, with a subsequent sensory blockade from T8 to L1.
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
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent until age range above 13 years old to ensure cooperation during data collection and adults with requirement to anterior iliac crest bone grafting for intraoral grafting.
- •Having no tumour or trauma in the lower limbs or ilium
- •Having no any other neural or muscular disorder which may merge with gait disturbance
- •Having no cognitive deficiency which may prevent understanding and performing of the study protocol.
排除标准
- •Patients with rheumatic disorders, low back pain, prosthesis of the hip or knees or previous iliac crest surgery.
- •Medical exclusion criteria are severe bronchopulmonary disease and cardiac problems affecting exercise tolerance, blood-clotting impairment, known allergy to the trial drugs, abdominal wall infection, morbid obesity (˃38 kg/m2).
- •Reported allergy to any of the drugs used.
- •Failure to follow up the accelerometry-derived data.
研究组 & 干预措施
Group (B)
Patients received the transversus abdominis plane block in-addition to the regular General Anaesthesia protocols.
干预措施: Transversus Abdominis Plane Block (Other)
Group (A)
Patients with requirement to anterior iliac crest bone grafting for intraoral transplantation without intervention.
结局指标
主要结局
Difference in Distance
时间窗: Third week postoperatively
Difference in Distance in meters totally covered through one week preoperative and third week postoperative.
次要结局
- Rate of increase in Distance(Third week postoperatively)
- Rate of increase in number of steps(Third week postoperatively)
- Time in minutes to start walking after full recovery(12 hours postoperatively)
- Need of using walking aid(Third week postoperatively)
- Time in hours to develop worst pain(24 hours postoperatively)
- Duration of the bone harvesting procedure(Intraoperatively)
研究者
Abdalkahar Shawki
B.D.S of Oral and Maxillofacial Surgery Department, Ain-Shams University, Cairo, Egypt.
Ain Shams University