Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
2016年3月7日 更新者：Children's Hospital Medical Center, Cincinnati
The purpose of this study is to determine if an intravenous lidocaine infusion (compared to placebo) intraoperatively will decrease time to return of bowel function postoperatively, decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory markers and shorten time to discharge after colorectal surgery.
調査の概要
詳細な説明
Lidocaine is an amide local anesthetic that has analgesic and anti-inflammatory properties.
Lidocaine infusion is a very useful pain medication that is underutilized to treat surgical, chronic, and cancer pain in children.
The investigators propose to examine the perioperative use of lidocaine infusion in children undergoing colorectal surgery that involves an abdominal incision.
The investigators plan to measure the following outcomes: length of stay in hospital following abdominal surgery, postoperative pain scores, cumulative morphine consumption, incidences of opioid adverse-effects: respiratory depression, sedation, nausea, vomiting, time to passage of flatus, time to first bowel movement and end-tidal Sevoflurane in operating room throughout surgery.
The following laboratory values will be measured: serial lidocaine levels of pharmacokinetics and safety levels, Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA and genetic variants.
研究の種類
介入
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1年～15年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- male or female children 1-15 years of age
- ASA physical status 1-3
- scheduled for colorectal surgery with abdominal incision
- scheduled for complex urology surgical case
Exclusion Criteria:
- ASA physical status > 3
- postoperative intubation planned ahead of surgery
- history of chronic use of opioid
- history of hepatic,renal, or cardiac failure
- history of organ transplant
- BMI > 30
- history of cardiac arrhythmia
- history of long QT syndrome
- history of allergic reaction to lidocaine or similar agents
- history of seizure disorder
- patient without Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction
- family history or know patient susceptibility to malignant hyperthermia
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes.
The bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion
|
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump.
This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.
|
|
プラセボコンパレーター：Saline
The saline will be administered over an infusion pump over 10 minutes and followed by a bolus.
The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion.
|
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump.
This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of stay in hospital following abdominal surgery
時間枠：participants will be followed for the duration of hospital stay, an average of 1 week
|
The primary outcome measure will be to monitor the length of stay in hospital following abdominal surgery.
|
participants will be followed for the duration of hospital stay, an average of 1 week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain scores
時間枠：participants will be followed post-op, average 5 days
|
Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.
|
participants will be followed post-op, average 5 days
|
|
Cumulative morphine consumption
時間枠：participants will be followed post-op, average 5 days
|
Staff will document how much morphine a patient uses post-operatively after abdominal surgery.
|
participants will be followed post-op, average 5 days
|
|
Incidences of opioid adverse-effects
時間枠：participants will be followed post-op, average 5 days
|
Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting
|
participants will be followed post-op, average 5 days
|
|
Time to passage of flatus and bowel movement
時間枠：participants will be followed post-op, average 5 days
|
Study staff will review nursing notes for time of passage of flatus and first bowel movement.
|
participants will be followed post-op, average 5 days
|
|
End-tidal Sevoflurane in operating room throughout surgery
時間枠：participants will be measured until the end of the OR case, on average 6 hours
|
participants will be measured until the end of the OR case, on average 6 hours
|
|
|
Serial lidocaine levels for pharmacokinetics and safety levels
時間枠：participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
|
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
|
Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA
時間枠：participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
|
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
|
Genetic variants
時間枠：participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
|
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Smokey J Clay, MD、Children's Hospital Medical Center, Cincinnati
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
- Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.
- Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. doi: 10.1111/j.1460-9592.2007.02213.x.
- Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. doi: 10.1542/peds.110.3.e33.
- Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Ash-Bernal R, Wise R, Wright SM. Acquired methemoglobinemia: a retrospective series of 138 cases at 2 teaching hospitals. Medicine (Baltimore). 2004 Sep;83(5):265-273. doi: 10.1097/01.md.0000141096.00377.3f.
- McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.
- Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Candiotti KA, Yang Z, Morris R, Yang J, Crescimone NA, Sanchez GC, Bird V, Leveillee R, Rodriguez Y, Liu H, Zhang YD, Bethea JR, Gitlin MC. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology. 2011 May;114(5):1162-8. doi: 10.1097/ALN.0b013e318216e9cb.
- Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
- Annabi EH, Barker SJ. Severe methemoglobinemia detected by pulse oximetry. Anesth Analg. 2009 Mar;108(3):898-9. doi: 10.1213/ane.0b013e318172af73.
- LUND PC, CWIK JC. PROPITOCAINE (CITANEST) AND METHEMOGLOBINEMIA. Anesthesiology. 1965 Jul-Aug;26:569-71. doi: 10.1097/00000542-196507000-00020. No abstract available.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年1月1日
一次修了 (予想される)
2018年3月1日
研究の完了 (予想される)
2018年4月1日
試験登録日
最初に提出
2013年4月8日
QC基準を満たした最初の提出物
2013年4月17日
最初の投稿 (見積もり)
2013年4月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月8日
QC基準を満たした最後の更新が送信されました
2016年3月7日
最終確認日
2016年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CCHMC 2012-0674
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Lidocaineの臨床試験
-
Allergan Medical完了
-
BioplusAsan Medical Center; Seoul National University Hospital; Soonchunhyang University Hospital招待による登録