Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
調査の概要
詳細な説明
This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).
The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.
Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.
The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
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:
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Exclusion Criteria:
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Normal saline will be infiltrated
|
placebo injection in the Pfannenstiel incision
|
|
アクティブコンパレータ：Intervention
Liposomal bupivacaine will be infiltrated
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liposomal bupivacaine injection in the Pfannenstiel incision
他の名前：
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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 |
|---|---|---|
|
Pain Score With Activity
時間枠：at 48-hours post-operatively
|
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39 |
at 48-hours post-operatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Score With Activity
時間枠：at 72 -hours post-operatively
|
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment |
at 72 -hours post-operatively
|
|
Total Opioid Use (in Morphine Equivalents)
時間枠：72-hours post-operatively
|
Total opioid use (in morphine equivalents)
|
72-hours post-operatively
|
|
Satisfaction With Post-operative Pain Control
時間枠：48-hours post-operatively
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PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied
|
48-hours post-operatively
|
|
Postoperative Hospital Length of Stay
時間枠：0 to 96 hours postoperatively
|
Postoperative hospital length of stay
|
0 to 96 hours postoperatively
|
|
Number of Patients With Wound Complication - Separation, Dehiscence, Infection
時間枠：14 days postoperatively
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Wound complication - separation, dehiscence, infection
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14 days postoperatively
|
|
Number of Patients With Allergic Reaction Attributable to Local Anesthestic
時間枠：0-96 hours postoperatively
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incisional rash, hives, anaphylaxis
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0-96 hours postoperatively
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Operative Time of Cesarean Delivery
時間枠：Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
|
Operative time of cesarean delivery
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Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
|
|
Patient Satisfaction With Pain Management at 6w Postpartum
時間枠：6 weeks postpartum
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Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used
|
6 weeks postpartum
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協力者と研究者
捜査官
- 主任研究者：William H Barth, Jr, MD、Massachusetts General Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
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