Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis - a Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Self-reported pain scores at 3 hours post-operatively
研究概览
简要总结
The study will investigate the pain control effects of a rectus sheath block after laparoscopic surgery to remove the appendix. A rectus sheath block is the injection of local anesthetic (numbing agent) into the space between the muscles of the belly wall. Children having surgery for appendicitis age 8-17 at the Stollery Children's Hospital will be eligible to participate. Patients with complicated appendicitis (perforation or abscess), chronic pain, bleeding disorders, or inability to document pain scores will be excluded from this study.
Participants will be randomly assigned to either rectus sheath block or standard local anesthetic. The standard local anesthetic group will have local anesthetic (numbing agent) injected around their surgery cut sites. The rectus sheath block group will have this standard plus the rectus sheath block with local anesthetic. Participants, parents, anesthesiologists and nursing staff will not know which group the participant has been assigned to. The surgeon will know the group.
The same pain and nausea medications will be ordered for all participants after the surgery. Pain scores will be measured using the Faces Pain Scale - Revised tool. Participants will be asked to rate their pain in the recovery room, in their hospital room at 3 and 6 hours after the surgery and again before going home. This tool has been shown to be useful for rating children's pain levels. The study will also measure the amount of pain and nausea medications that participants are given during their surgery and recovery. Participants will see their surgeon at 6 weeks after their surgery where they will be asked about any problems after being discharged home. Data will be analyzed with a linear mixed model.
详细描述
Purpose:
To determine if a bilateral laparoscopically guided rectus sheath block improves pain control over conventional local anesthetic infiltration around port site incisions following laparoscopic appendectomy.
Hypothesis:
Bilateral rectus sheath block will improve post-operative pain scores following laparoscopic appendectomy for acute uncomplicated appendicitis.
Justification:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Single-blind. Surgeon cannot be blinded to the intervention. Anesthesiologist, participants, parents, and nursing staff in the OR, recovery room, and ward will be blinded.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute uncomplicated appendicitis
- •Age 8-17 years
排除标准
- •Complicated appendicitis, perforation, abscess
- •History of chronic pain condition or long-term analgesic use
- •History of bleeding condition
- •Condition preventing accurate documentation of post-operative pain scores using the FPS-R tool including severe developmental delay, psychiatric illness, or partially sighted or blindness
- •Previous open abdominal surgery
- •Presence of an abdominal prosthesis such as a gastrostomy tube or ventricular-peritoneal shunt device
- •Allergy to bupivacaine or morphine
结局指标
主要结局
Self-reported pain scores at 3 hours post-operatively
时间窗: 3 hours
Reported with Faces Pain Scale - Revised. Scale runs from 0-10 with 0 being no pain and 10 being the worst pain they have experienced.
次要结局
- Intra-operative narcotic use in mg/kg morphine equivalents(Intra-operative)
- Post-operative narcotic use in mg/kg morphine equivalents(Approximately 24 hours)
- Post-operative anti-emetic use mg/kg or ondansetron and dimenhydrinate(Approximately 24 hours)
- Self-reported pain scores in recovery room, at 6 hours post-operatively, and prior to discharge home(Immediately post-operatively to approximately 24 hours)