Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control: Is it the Concentration or Volume of Local Anesthetic Solution That Improves Analgesia?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain
研究概览
简要总结
After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may experience some amount of pain in the post-operative period. As part of the anesthesia technique, the investigators routinely provide a nerve block done on the abdominal wall that will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP block. The purpose of this study is to determine if the nerve block performed with local anesthetic solution using a regular concentration solution vs. a diluted solution may offer different durations of pain relief.
详细描述
Children undergoing groin surgery or abdominal surgery under general anesthesia are offered pain relief postoperatively using regional anesthesia techniques including a central block like a caudal block, or peripheral nerve blocks including ultrasound guided ilioinguinal nerve block or transversus abdominis plane (TAP) block. The TAP block, a peripheral block of the thoraco-lumbar nerve roots as they exit between the internal oblique and the transversus abdominis muscle can be easily visualized using ultrasound guidance. The TAP block has been used for analgesia following major surgeries including lower abdominal surgeries and in newborn infants following major abdominal procedures including colostomy placement.1 The purpose of this study is to determine if two different concentrations of bupivacaine delivered at a total dose of 1 mL/kg offer similar or altered analgesia, i.e., does the concentration of the anesthetic matter more than the volume of local anesthetic while performing a TAP block in children undergoing groin surgery. Parents and the investigators will be blinded to the solution used for the TAP block. The solution will be drawn up by an investigator who is not a participant in the patient's care in a sterile fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 8 years of age presenting for hernia repair, hydrocelectomy or lower abdominal surgery
- •Estimated operative time approximately 3 hours
- •American Society of Anesthesiologists Classification ASA I or II
- •Parental consent to be included in the study
排除标准
- •Any contraindications to local anesthesia but not limited to
- •Local infection of the abdominal wall.
- •Allergy to amide local anesthetics
- •History of significant cardiac disease or uncontrolled seizures.
- •Allergy to rescue analgesia including acetaminophen and or hydromorphone.
- •Neonates under 28 days.
- •Inability for the family to complete the postoperative questionnaire
研究组 & 干预措施
0.25% Bupivacaine
All children will receive a single dose of 1 mcg/kg of Fentanyl intravenously prior to incision. Group TAP 1 receiving a TAP block with 0.25% bupivacaine with 1:200,000 epinephrine at a dose of 1 mL/kg.
干预措施: Bupivacaine (Drug)
0.125% Bupivacaine
All children will receive a single dose of 1 mcg/kg of Fentanyl intravenously prior to incision. Group TAP 2 will receive a TAP block with a total dose of 1 mL/kg given at a concentration of 0.125% bupivacaine with 1:200,000 epinephrine.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain
时间窗: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
The difference in concentrations will be measured by using FLACC score every 5 mins for one hour after surgery in the Post Anesthesia Care Unit. Blood pressuer and heart rate will also be recorded.
次要结局
- Dose of rescue medications given between the two groups(Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours)
- Number of rescue medications given between the two groups(Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours)
- Time the rescue medications were administered between the two groups(Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours)