TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- In-hospital Postoperative Opioid Consumption
研究概览
简要总结
The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.
详细描述
Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.
Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).
In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
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
- •18 years of age or older
- •Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery
排除标准
- •Allergic to local anesthetics
- •Unable to provide consent
- •On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
- •Undergoing emergent operations
- •Undergoing loop ileostomy reversal
- •Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs
研究组 & 干预措施
Standard Bupivacaine
Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
干预措施: Bupivacaine (Drug)
Bupivacaine Liposome
Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
In-hospital Postoperative Opioid Consumption
时间窗: up to postoperative day 3 at 1 pm
Daily overall opioid use recorded as morphine equivalents
次要结局
- Pain Score(Approximately every 6 hours through postoperative day 3 by 1 pm)
- Time to Patient Mobilization(From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Return of Bowel Function(From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Clear Liquid Diet(From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Low Fiber Diet(From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).)
- Length of Stay(Date of surgery to date of discharge (usually up to 4 days after surgery).)
- In-hospital Antiemetic Use(Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).)
- Complications(Within 30 days of surgery)
- Readmissions(Within 30 days of hospital discharge)
- Mortality(Within 30 days of surgery)
- Hospitalization Costs(From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).)