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临床试验/NCT01707251
NCT01707251已完成4 期

Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

Jacobi Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
24 hours postoperative morphine requirement using IV PCA

研究概览

简要总结

Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.

详细描述

Investigators will recruit patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center (100 patients with allowance for 20% drop-offs). Patients will be randomized to IV Ibuprofen versus placebo to test if morphine usage can be decreased, pain control improved, pressure pain thresholds increased and respiratory depression decreased.

Exclusion/withdrawal criteria:

Patients with history of ibuprofen or aspirin allergy, morphine allergy, opioid or psychotropic medication use pre-operatively, patients who would show positive preoperative U-tox screening, patients unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity will be excluded. Patients with GFR<60 or history of GI bleed within 6 weeks will be excluded. Patients will be withdrawn from the study if PCA would have to be discontinued, or the patient would develop acute renal failure, GI bleed or post-surgical bleed. Intention to treat analysis will be performed including the dropouts.

Patients' instructions and protocol:

Patients consented for the study will be educated about morphine PCA for pain control and about pain reporting using NRS-11 and VAS scale at rest and with cough or during incentive spirometry. They will receive instructions about Remmers Sleep Recorder (SagaTech Calgary, Alberta, Canada), which includes continuous oximetry, and device will be provided for overnight home screening preoperatively {Whitelaw,W.A. 2005;}. The sleep recorder data will be reviewed pre-operatively and patients with respiratory disturbance index (RDI, measured as oxygen desaturation event) >15/hour who do not have OSA diagnosis and do not use CPAP will be referred for sleep study and/or CPAP titration before the surgery, Patients will be educated on QST testing using pressure algometry with 1cm2 padded tip {Coronado 2010} and will be given survey questionnaire (postoperative diary) for self-reporting of pain (VAS at rest and with cough), nausea/vomiting, activity and side effects from medications as well as satisfaction with recovery and pain control. Baseline pressure pain thresholds (N/cm2) will be tested at abdomen (area of postoperative hyperalgesia) and the pulp of third finger finger on the right (reference site) using average of three measurements per site.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center

排除标准

  • Patients with history of ibuprofen or aspirin allergy
  • morphine allergy
  • opioid or psychotropic medication use pre-operatively
  • positive preoperative U-tox screening
  • unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity
  • GFR <60 or history of GI bleed within 6 weeks

研究组 & 干预措施

Intravenous Ibuprofen

Experimental

800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).

干预措施: Intravenous Ibuprofen (Drug)

Saline

Placebo Comparator

IV saline every 6 hours starting preoperatively (5 doses).

干预措施: Saline (Drug)

结局指标

主要结局

24 hours postoperative morphine requirement using IV PCA

时间窗: 24 hours

Will test if IV ibuprofen decrease postoperative morphine requirement.

次要结局

  • Respiratory depression(24 hours postoperative)
  • Pain scores(24 hours postoperatively)
  • Pressure pain thresholds(24 hours)

研究者

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

Mindaugas Pranevicius

Attending Anesthesiologist, Director of Pain Medicine

Jacobi Medical Center

研究点 (1)

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