Randomized Clinical Trial Examining Use of Adjunct EXPAREL for Post-tonsillectomy Pain Management in Adults
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days
研究概览
简要总结
Tonsillectomy is one of the most commonly performed surgical procedures in the United States. The primary indications for tonsillectomy in the adult population include recurrent pharyngitis, chronic tonsillitis, and obstructive pathology. Tonsillectomy is often associated with severe postoperative pain, which can result in prolonged poor oral intake, dehydration, and the need for high dose narcotics. In severely dehydrated patients, epithelial shedding and necrosis of soft tissues at the surgical site can lead to postoperative complications such as bleeding, delayed healing, and severe pain. The goal for this study is to explore the use of a long acting local anesthetic bupivacaine liposome injectable suspension (Exparel) to manage pain experienced by adult patients after tonsillectomy
详细描述
The proposed investigation will examine whether Exparel (bupivacaine liposome injectable suspension 1.3%-13.3 mg/mL) when used as a post-excision adjunct to the standard of care bupivacaine HCl 0.25% (2.5 mg/mL) with Epinephrine (5mcg/mL), will decrease the patient's post-tonsillectomy experience of pain intensity, especially for the first three days after surgery, and correspondingly reduce the requirement for pain medications and improve outcomes.
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, Outcomes Assessor)
盲法说明
Using sealed envelope assignment, the participant will be placed in study Arm 1 or 2. The PI will not be masked because the PI will administer the adjunct treatment or the standard of care only. The outcome assessor will be masked to study group assignment for gathering data from trial participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo bilateral palatine tonsillectomy as the only procedure
- •Adults age 18 years and older.
排除标准
- •Severe systemic disease that is clinically significant in the judgement of the investigator.
- •Coagulation disorder that is clinically significant in the judgement of the investigator.
- •Current or previous history of analgesic dependence
- •Allergy to any of the drugs used in the study (bupivacaine)
- •Women known to be pregnant, planning to become pregnant, or lactating
- •Hearing impairment that is clinically significant in the judgement of the investigator.
- •Cardiovascular disease that is clinically significant in the judgement of the investigator.
- •Impaired liver function that is clinically significant in the judgement of the investigator.
- •Impaired renal function that is clinically significant in the judgement of the investigator.
- •Unable to provide consent.
- •Additional surgical procedures planned concurrently with palatine tonsillectomy.
- •Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.
研究组 & 干预措施
Adjunct Exparel
After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side. Following the standard medication, the principal investigator will infiltrate 0.5 mL of adjunct Exparel (bupivacaine liposome suspension 1.3% [13.3 mg/mL], i.m.) into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine liposome injectable suspension on each side.
干预措施: Adjunct Exparel (bupivacaine liposome suspension 1.3%) (Drug)
Adjunct Exparel
After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side. Following the standard medication, the principal investigator will infiltrate 0.5 mL of adjunct Exparel (bupivacaine liposome suspension 1.3% [13.3 mg/mL], i.m.) into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine liposome injectable suspension on each side.
干预措施: Standard Care (Other)
Standard Care
After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/ mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side.
干预措施: Standard Care (Other)
结局指标
主要结局
Change in pain rating between post anesthesia care unit (PACU) baseline and designated post-operative days
时间窗: Post-tonsillectomy Days 1, 2, 3, 5, and 10
Patient reported average and maximum pain rating over a 24-hour period using the St. Joseph Mercy Ann Arbor (SJMAA) standard visual analog 11 point pain rating scale. The minimum value of 0 indicates no pain and the maximum value of 10 indicates the worst possible pain. A higher value represent greater pain and a worse outcome. The baseline pain rating is the maximum rating from PACU on the day of surgery. Day-1 begins at 12:00 AM (after midnight) day of surgery and extends through 11:59 PM. Each following designated day will begin at 12:00 AM and extend through 11:59 PM.
次要结局
- Change in total amount of prescribed narcotic pain medication taken between Day-1 and designated post-operative days(Post-tonsillectomy Days 1, 2, 3, 5, and 10)
- Change in the total amount of over the counter pain medication taken between Day-1 and designated post-operative days(Post-tonsillectomy Days 1, 2, 3, 5, and 10)
研究者
Paul Hoff
Principal Investigator
Saint Joseph Mercy Health System