A Study of Postsurgical Pain Control for Lower Extremity Fractures
A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.
調査の概要
詳細な説明
All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical fixation would be included. Written, informed consent to enrollment will be recorded and included in the patient record. The study is designed around the standard of care for postsurgical pain management. There are no additional costs to the patient strictly related to this study.
Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical investigators at a single institution. A sealed, opaque envelope, selected in the pre-operative holding area, will accompany each patient participant to the operating room. The envelope will be opened at the conclusion of the fracture fixation to reveal patient assignment to either study Group 1 or Group 2. Once the total numbers of patients have completed their procedures and follow-up, the study will close.
研究の種類
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Florida
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Ft. Lauderdale、Florida、アメリカ、33316
- Broward Health Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients over 18 years of age
- Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation
Exclusion Criteria:
- Allergy to ExparelTM or certain other local anesthetic agents
- Surgery performed at an outside institution or by a different surgeon
- Chronic analgesic users (defined as use of opioid medication >14 days in the past 3 months, or use of non-opioid pain medication >5 times per week
- Pregnant females or females who think they may become pregnant
- Peripheral neuropathy
- Major psychiatric disease
- Inability to comprehend the nature of the study
- Unwillingness to provide signed informed consent
- Markedly abnormal kidney function or renal disease
- Non-English speaking
- Signs or symptoms of compartment syndrome
研究計画
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Control- Marcain
Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
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The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes.
Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure.
Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure.
Study participants will undergo injection in this manner until the conclusion of the study.
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実験的:Experimental- Exparel
Group 2 will receive a mixture of non-liposomal bupivacaine and Exparel introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
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The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes.
Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure.
Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure.
Study participants will undergo injection in this manner until the conclusion of the study.
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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 |
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Change in Pain Visual Analogue Scale (VAS)
時間枠:72 hours
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Patients will be asked to complete a Pain Visual Analogue Scale every 2 hours for the first 12 hours of their stay (2, 4, 6, 8, 10, 12), and then again at 24, 30 and 72 hours into their hospitalization.
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72 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Pain Management Satisfaction
時間枠:2 weeks, post-operatively
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Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.
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2 weeks, post-operatively
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Brian J Cross, MD、Broward Health
出版物と役立つリンク
一般刊行物
- References 1-Candoitti 2012 2-Gupta Curr Opin Anaesthesiol 2010, Liu J Am Coll Surg 2006 3-Lynch Anesth Analg 1997, Amin J Surg Pakistan 2010 4-Golf Adv Ther 2011, Onel 2011, Bergese IARS Annual Meeting 2011 5-Angst Clin Pharmacokinet 2006, Howell Cancer J 2001
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
Bupivacaine/Exparelの臨床試験
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University of California, San Francisco完了
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University of California, San DiegoPacira Pharmaceuticals, Inc完了
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Pacira Pharmaceuticals, Inc完了
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University of Washingtonわからない痛み、術後 | 局所麻酔 | 麻酔 | オピオイドの使用 | 麻酔;機能的