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临床试验/NCT02483689
NCT02483689Unknown不适用

The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies

Valley Anesthesiology Consultants1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Amount of Post Operative Pain Patients Experience

研究概览

简要总结

Patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random.

The clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied.

Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess the timing of local anesthetic injection affects postoperative pain.

详细描述

This is a prospective randomized-controlled pilot study of 100 pediatric subjects, recruited through Phoenix Children's Hospital and Pediatric Surgeons of Phoenix, who will undergo a laparoscopic appendectomy (LA) for acute non-perforated appendicitis. The reviewer and subject will be blind to the treatment to help prevent bias. The subjects will be randomized by envelope using a random number generator, and the infiltrated solution will be given to the surgeon by the pharmacy.

The subjects will be approached preoperatively and will be divided into three groups: pre-incisional injection of local anesthetic, post-incisional injection of local anesthetic, and (pre or post) injection of saline as the control.

All patients will have a standard 3 port laparoscopic appendectomy, port placement, port and instrument type, and operative technique will be determined by the surgeon's usual practice.

On induction, the following protocol will be utilized: a 2 mg/kg bolus of propofol, 1.5 mg/kg of lidocaine, 0.1 mg/kg of morphine, and 0.6 mg/kg of rocuronium. A standardized anesthetic, using a mixture of sevoflurane in oxygen and air, will be utilized. Once the appendectomy is complete, a single dose of 0.5 mg/kg of ketorolac will be given prior to extubation. A total of 0.5 mL/kg of 0.25% Bupivicaine or saline, up to a maximum of 30 cc, will be injected using a 22g needle. Pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; post-closure local will be injected intradermally after closure.

The subjects will be assessed for postoperative pain immediately upon wakening, and then 1, 2, 4, 8, 12, and 24 hours after the LA procedure by the bedside nurse by using the VAS and by measuring the total amount of opioid use.

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, Investigator)

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between 9-17 years old

排除标准

  • 未提供

研究组 & 干预措施

Saline

Placebo Comparator

Patient will be given saline with a maximum of 30 cc either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

干预措施: Pre-Incisional Saline (Other)

Saline

Placebo Comparator

Patient will be given saline with a maximum of 30 cc either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

干预措施: Post-Closure Saline (Other)

Local

Experimental

Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

干预措施: Pre Incisional Local Anesthetic (Drug)

Local

Experimental

Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

干预措施: Post-Closure Local Anesthetic (Drug)

结局指标

主要结局

Amount of Post Operative Pain Patients Experience

时间窗: 12 hours

The subjects will be assessed for post-operative pain immediately upon wakening, then at 1, 2, 4, 8, and 12 hours after procedure.

次要结局

  • The total amount of opioid use(24 Hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neil Raj Singhal

Doctor

Valley Anesthesiology Consultants

研究点 (1)

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