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临床试验/NCT00405262
NCT00405262已完成3 期

The Effectiveness of Bupivicaine Infusion Versus Intravenous Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting for Lefort I Osteotomy or Alveolar Cleft Repair.

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
54
试验地点
1
主要终点
Pain, assessed with a numerical analog system

研究概览

简要总结

The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain.

详细描述

Iliac crest bone grafts (ICBG) are used for many types of surgeries including alveolar cleft repair, Lefort I osteotomies, spinal fusion, and fracture management. ICBG donor sites are notoriously painful, and the pain is often more severe than that from the primary operative site.

Postoperative pain management after operations that involve harvesting ICBG usually includes opioids, which are most often delivered by a patient-controlled device. Additional analgesics may include acetaminophen, non-steroidal anti-inflammatory (NSAID) drugs, and local anesthetic agents, such as bupivacaine or ropivacaine. Local anesthetics may also be injected intermittently or continuously into the wound via an indwelling catheter inserted at the time of surgery. All but one of these studies have shown a significant reduction in pain scores and opioid consumption using local anesthetic through an indwelling catheter.

Only one study has investigated the effects of NSAIDs on postoperative ICBG pain. This study found that intravenous ketorolac did not reduce morphine consumption. However, there was a trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not measured.

Currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter for patients at our institution undergoing Lefort I osteotomy or alveolar cleft repair with ICBG since we find the above pain management regimen to be effective, with most patients using low to moderate amounts of morphine. To our knowledge, no study to date has compared the efficacy of ketorolac to local anesthetic infusions for patients undergoing Lefort I osteotomy or alveolar cleft repair with ICBG.

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
Double (Participant, Investigator)

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Alveolar bone graft patients age 10-13 years of age
  • Lefort I osteotomy patients needing ICBG age 14 to 20 years
  • able to operate a patient-controlled analgesia (PCA) device

排除标准

  • Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
  • Allergy, sensitivity or contraindication to morphine
  • History of gastric ulcer or bleeding diathesis

研究组 & 干预措施

1

Active Comparator

干预措施: Ketorolac (Drug)

2

Experimental

干预措施: Bupivacaine (Drug)

3

Experimental

干预措施: ketorolac + bupivacaine (Drug)

结局指标

主要结局

Pain, assessed with a numerical analog system

时间窗: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours

Patient satisfaction score

时间窗: 24 hours

次要结局

  • Total number of episodes of nausea, vomiting, and pruritis(48 hours)
  • Doses of all anti-emetics(48 hours)
  • Heart rate and respiratory rate variables(48 hours)
  • Time to first ambulation(Time determined by outcome)
  • Wound healing at iliac crest site(1, 4, 8 and 16 weeks post-operatively)
  • Morphine consumption(Every 4 hours)
  • X-ray data on recipient site(1, 4, 8 and 16 weeks post-operatively)
  • Clinical assessment of recipient site(1, 4, 8 and 16 weeks post-operatively)
  • Plasma bupivacaine levels(Before bolus and at 0.5, 1, 6, 12 and 24 hours)

研究者

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

Jason Hayes

Staff Anesthesiologist

The Hospital for Sick Children

研究点 (1)

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