Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Post Operative Pain Rating
研究概览
简要总结
This is a prospective, double-blinded, randomized controlled study comparing the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the incision for providing post-operative analgesia following umbilical hernia repair in children. The current management for reducible umbilical hernias is umbilical hernia repair under general anesthesia as an outpatient procedure.
Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study inclusion. Eligible patients and their parents/guardians will be approached and, if agreeable, consented for the study pre-operatively. Patients will be randomized to receive either pre-incisional percutaneous rectus sheath block by the anesthesiologist or intra-operative rectus sheath block under direct visualization prior to closure of the skin incision by the surgeon. The patient, patient guardians, select research team members, and post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.
详细描述
Regional anesthesia has been increasingly utilized for providing post-operative analgesia for a number of surgical procedures in children. Rectus sheath block and local anesthetic infiltration of the surgical site are two common modes for providing post-operative analgesia following umbilical hernia repair. Studies comparing the two modes have shown ultrasound-guided rectus sheath block to improve immediate pain scores and reduce use of post-operative analgesia in pediatric patients undergoing umbilical hernia repair. However, these studies have compared pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic infiltration as a subcutaneous and/or intradermal injection.
The purpose of the investigators' study is to compare the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the skin for providing post-operative analgesia following umbilical hernia repair in children.
The investigators propose a prospective study where pediatric patients who are undergoing elective umbilical hernia repair will be randomized pre-operatively to receive either pre-incisional, ultrasound guided percutaneous rectus sheath block or intra-operative rectus sheath block under direct visualization prior to closure of the skin. The primary outcome is the post-operative pain rating based on the Wong-Baker Faces Pain Rating Scale (WBFPRS) following umbilical hernia repair. Additional outcomes measured will include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in the post-operative period, duration of analgesia following surgery based on time to first rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes, incidence of side-effects, and complications. Patients/patient guardians will receive a sheet to document post-operative WBFPRS scores, oral opioid and non-opioid medication administration once discharged to home for a total of 5 days.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 3-18 years undergoing elective umbilical hernia repair
排除标准
- •Strangulated or incarcerated umbilical hernia (non-elective)
- •Allergy to bupivacaine/ropivicaine
- •Concurrent surgical procedures
- •Developmental delay or neurologic diagnosis that would interfere with post-operative pain score assessment
- •Chronic pain medication use
- •Chronic pain disorder or complex regional pain syndrome
- •Anesthesiologist classification of III or greater.
研究组 & 干预措施
Pre-op percutaneous rectus sheath block
ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
干预措施: Pre-op percutaneous rectus sheath block (Procedure)
Pre-op percutaneous rectus sheath block
ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
干预措施: Ropivacaine (Drug)
Intra-operative rectus sheath block
rectus sheath block with ropivacaine under direct visualization by the attending surgeon
干预措施: Intra-operative rectus sheath block (Procedure)
Intra-operative rectus sheath block
rectus sheath block with ropivacaine under direct visualization by the attending surgeon
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Post Operative Pain Rating
时间窗: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported
次要结局
- Pain Score of Zero(from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours)
- Time to First Narcotic(from entry in post-anesthesia care unit (PACU) to first narcotic)
- PACU Morphine Equivalents(from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours)
- PACU Length of Stay (LOS)(from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours)