The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
研究概览
简要总结
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.
详细描述
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: 2. Time (hours/minutes) for numbness due to local anesthetic to wear off 3. Number of tablets of ibuprofen and acetaminophen consumed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Subjects will be randomized to one of the two groups with simple randomization. Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope with the intervention named inside and hand it to the PI. The PI will prepare the solution selected in a non-labeled syringe and hand it to the surgeon. The surgeon, patient and faculty staffing the case will be blinded as to the contents of the syringe
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (Drug)
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.
干预措施: 0.5% Bupivacaine HCl (Drug)
结局指标
主要结局
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
时间窗: 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.
次要结局
- Time for numbness to wear off(3 to 168 hours)
- Number of of anti-inflammatory tablets taken(Baseline to 7 days)
- Number of analgesic tablets taken(Baseline to 7 days)
研究者
Angela Palaiologou-Gallis, DDS, MS
Professor and Program Director, Graduate Periodontics
The University of Texas Health Science Center at San Antonio