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Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management

2018年6月28日 更新者:Benjamin Domb、American Hip Institute

Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.

The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.

調査の概要

詳細な説明

All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB group) and the other receiving bupivacaine with epinephrine (Control group), will be compared using post-operative pain scores, hospital length of stay, time to ambulation, falls, narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was performed to calculate the total number of patients that needed to be enrolled to achieve a minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least 26 patients were necessary in each group for an adequately powered assessment. The diagnosis for osteoarthritis was determined by patient history, physical examination, and imaging findings. Each patient received a thorough explanation of the protocol, and willing patients signed an informed consent form. All patients underwent a personal preoperative education program regarding pre, intra-, and post-procedural information including physical therapy, expectations, discharge goals, home therapy, and pain management. After written consent was collected, the form was sent to the hospital pharmacy for randomization. Envelopes were randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the envelopes to the nurse in the operating room in numerical order. The pharmacy documented the required information, selected medication, and drug accountability forms according to the contents of the envelopes.

A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope. During the standard anterior approach procedure, an anesthesiologist administered fentanyl or hydromorphone as needed for analgesia. The local anesthetics were administered after reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc 0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle, the local anesthetics were injected using a deep tissue administration technique. Structures innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve were considered suitable for injection. Throughout administration, frequent aspirations were performed to check for blood and minimize the risk of intravascular injection. The patients, surgical team, and floor staff was blinded to the local anesthetic drugs given.

During hospitalization, patients were observed, evaluated and treated according to postoperative protocols. Patients received opioids for pain management as needed, which was routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone, codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine equivalent dosages for analysis. Each patient began physical therapy within the first 24 hours postoperatively. Patients were discharged when they were able to begin self-care, their pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication intake.

研究の種類

介入

入学 (実際)

107

段階

  • フェーズ2

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

    • Illinois
      • Hinsdale、Illinois、アメリカ、60521
        • Adventist Hinsdale Hospital
      • Westmont、Illinois、アメリカ、60559
        • American Hip Institute

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

18年~90年 (大人、高齢者)

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:

  • Patients scheduled to undergo primary unilateral total hip replacement
  • Patients diagnosed with hip osteoarthritis
  • Patients failed to improve with conservative measures
  • Patients willing and able to sign informed consent

Exclusion Criteria:

  • Revision total hip replacement
  • Bilateral total hip replacement
  • Birmingham hip resurfacing
  • Patients with hepatic/kidney disease
  • Patients with a known allergy to bupivacaine or other local anesthetics

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:Liposomal bupivacaine
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
266mg liposomal bupivacaine
他の名前:
  • エクスパレル
0.25% bupivacaine with epinephrine
他の名前:
  • マルケイン
生理食塩水
他の名前:
  • 生理食塩水
アクティブコンパレータ:Bupivacaine with epinephrine
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% bupivacaine with epinephrine
他の名前:
  • マルケイン

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
Patient Morphine Equivalent Consumption
時間枠:72 hours postoperation, divided into six 12-hour periods
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
72 hours postoperation, divided into six 12-hour periods
Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
時間枠:72 hours post-operation, divided into six 12-hour periods
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.
72 hours post-operation, divided into six 12-hour periods
Time to Ambulation More Than 20 Feet (in Hours)
時間枠:from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.
from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
Length of Stay (LOS, in Days)
時間枠:From time of surgery until patient is discharged, an average of 1.5 days.
From time of surgery until patient is discharged, an average of 1.5 days.
Number of Patients That Experienced a Fall
時間枠:72 hours postoperation
72 hours postoperation

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。

スポンサー

捜査官

  • 主任研究者:Benjamin G Domb, MD、American Hip Institute

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。

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

2014年4月1日

一次修了 (実際)

2016年3月1日

研究の完了 (実際)

2016年3月1日

試験登録日

最初に提出

2016年11月8日

QC基準を満たした最初の提出物

2016年12月20日

最初の投稿 (見積もり)

2016年12月23日

学習記録の更新

投稿された最後の更新 (実際)

2018年7月26日

QC基準を満たした最後の更新が送信されました

2018年6月28日

最終確認日

2018年6月1日

詳しくは

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。

痛み、術後の臨床試験

Liposomal Bupivacaineの臨床試験

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