The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
Participants are being asked to be a part of this study because they have been scheduled to receive a gum surgery to treat periodontal (gum) disease. After agreeing to participate a pain and medication log will be provided to participants and a 5 minute survey given.
Standard of care gum surgery will be done using local anesthesia with or without intravenous sedation according to the participant's preference. If the participant is sedated, they will be asked to have an escort to take them home after the surgery as is the standard of care.
At this visit, after the surgery is complete, the doctor will inject the area next to the area that surgery was done surgery with 4 ml (about a teaspoon) of one of two solutions decided by a random 1:1 draw. The participant will receive either liposomal bupivacaine (Exparel) which is a long-acting local anesthetic or 0.5% Bupivacaine HCl with a small amount of epinephrine, a medium-acting dental anesthetic.
After surgery, as standard of care, participants will be given instructions on taking over-the-counter medications as needed for pain.
Participants will be asked to fill out the pain survey and tablet log at specific times after leaving the clinic.
A standard of care follow-up visit with the doctor will be scheduled about 2 weeks after the surgery.
調査の概要
詳細な説明
A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.
Primary Objective:
Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21)
Secondary Objectives:
- Time (hours/minutes) for numbness due to local anesthetic to wear off
- Number of tablets of ibuprofen and acetaminophen consumed
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 to 89 years old
- Require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures
- In either the maxillary or mandibular arch.
Exclusion Criteria:
- Pregnancy, or those planning to become pregnant
- Allergy or any medical issue using Bupivacaine
- Inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- Non-English speaking
- Patients requiring narcotic medications for IV sedation
- Patients requiring either IV or oral steroids during the perioperative period
- Patients with liver disease
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Adjunctive long acting local anesthesia post surgery
The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration
|
4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
|
|
アクティブコンパレータ：Adjunctive standard of care local anesthetic
The control group will receive a commonly used in dentistry local anesthetic (0.5% bupivacaine HCL) as an adjunctive analgesic after the end of the procedure.
|
4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery
|
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 |
|---|---|---|
|
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
時間枠：3 to 168 hours
|
Pain perceived at regular time intervals using a Visual Analogue Scale (NRS-21) rating their pain at specific time points on a scale from 0 to 10 with 0.5 points in between.
A higher score indicates more pain.
|
3 to 168 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time for numbness to wear off
時間枠：3 to 168 hours
|
Amount of time in hours/minutes for numbness due to local anesthetic to wear off
|
3 to 168 hours
|
|
Number of of anti-inflammatory tablets taken
時間枠：Baseline to 7 days
|
Number of ibuprofen/Motrin tablets taken post surgery
|
Baseline to 7 days
|
|
Number of analgesic tablets taken
時間枠：Baseline to 7 days
|
Number of acetaminophen tablets taken post surgery
|
Baseline to 7 days
|
協力者と研究者
捜査官
- 主任研究者：Angela Palaiologou-Gallis, DDS, MS、The University of Texas Health Science Center at San Antonio
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 (実際)
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
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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