Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine and Laparoscopic or Robotic Gynecology: A Randomized Controlled Trial (#2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Overall Benefit of Anesthesia Score (OBAS)
研究概览
简要总结
More than 600,000 hysterectomies are performed in the United States each year, making it the most common non-obstetric major surgery performed on women1. Estimates suggest that at least 30% of hysterectomies are performed laparoscopically or robotically with an increasing trend toward minimally invasive approaches2. While a minimally invasive approach certainly provides improved recovery, patients still experience substantial pain and most require opiate medications for pain control. Incorporating a multimodal approach to postoperative pain management through the use of field nerve blocks is potentially an ideal way to enhance recovery and minimize the need for narcotic pain medications.
Over the past decade, the use of Transversus Abdominis Plane (TAP) blocks as an adjunct for postoperative pain management has gained in popularity. First described in 2001 by Dr. Rafi of Limerick3, Ireland, TAP blocks are now typically performed by an anesthesiologist with the use of ultrasound guidance. The transversus abdominis plane is the neurovascular plane between the aponeurosis of the internal oblique and transversus abdominis muscles. Herein lie the afferent nociceptor nerve endings of T7-L1. Injection of a 20-30cc volume of anesthetic into this plane causes a sensory nerve block to the ipsilateral antero-abdominal wall from the costal margin to the symphysis pubis4.
Clinical trials have documented the validity of using TAP blocks for both open and laparoscopic procedures and verified their use for postsurgical pain relief. Studies have demonstrated that TAP blocks for both open and laparoscopic hysterectomies are safe and efficacious5, 6. In 2011, De Oliveira et al. demonstrated improved quality of recovery for women undergoing preoperative ultrasound guided TAP infiltration with ropivacaine at the time of laparoscopic hysterectomy7.
详细描述
The primary goal of our study is to demonstrate that laparoscopically assisted bilateral Transversus Abdominis Plane (TAP) block using liposomal bupivacaine is superior to pre-incisional injection of bupivacaine in terms of peri-operative opiate use, pain scores and overall patient satisfaction up to one week following surgery. Our recent research has already demonstrated the safety of performing Laparoscopic assisted TAP blocks using liposomal bupivacaine.
This trial will evaluate the efficacy of laparoscopic TAP blocks with liposomal bupivacaine by using VAS/numeric pain scores at rest and with cough in recovery at 1 and 2 hours post-op. The trial will also utilize an OBAS patient survey, document peri-operative opioid pain medication used intraoperatively, in PACU and overnight (if admitted), and assess length of time in PACU and same-day discharge versus admission. Opioid pain medication use at home up to one week will also be recorded.
HYPOTHESES/SPECIFIC AIMS The goal of this research project is to prove that a laparoscopically delivered TAP block using a combination of Liposomal bupivacaine (Exparel) and Bupivacaine is an effective and feasible means for decreasing post-operative pain from the immediate post-operative period up to one week.
The research aims to demonstrate that TAP blocks, when delivered laparoscopically and by using Liposomal bupivacaine will show a 20% benefit in post-operative QoR-15 scores on post-operative days 1,2 and 7. Other objectives of our study will be to evaluate peri-operative narcotic medication dosing, VAS/Numeric pain scores with cough at 1 and 2 hours in PACU, overnight narcotic use for patients who are admitted and narcotic pain pill use at home up to 7 days. Finally, the study aims to confirm that this technique is simple to perform, easy to implement and would offer a multi-modal anesthetic alternative to the excessive use of post-operative opioid pain medications.
Patients scheduled for laparoscopic or robotic hysterectomy are screened in the pre-anesthesia care unit and if eligible are invited to enroll in the trial. Primary Attendings for each surgery will advise patients of the option for the trial at pre-operative appointments. Patients who agree to enrollment are appropriately consented and then randomized to either control (pre-incisional anesthetic) or study (TAP) group. The patient remains blinded to the arm of the study, but OR personnel are advised so as to prepare medications and syringes.
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
- Single (Participant)
盲法说明
Participants will not know which type of injection they have received for pain control.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult women
- •undergoing laparoscopic robotic assisted laparoscopic hysterectomy with or without removal of adnexa
- •Simultaneous procedures such as appendectomy, excision of endometriosis or pelvic lymph node dissection not an exclusion
排除标准
- •Not undergoing laparoscopic hysterectomy
结局指标
主要结局
Overall Benefit of Anesthesia Score (OBAS)
时间窗: Post operative day 7
Change in resting pain, vomiting, itching, sweating, freezing, dizziness, satisfaction Likert 0-10 0=not at all, 10- very much
次要结局
- OBAS Questionnaire(Post operative day 2)