Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Compare laparoscopic-guided TAP block timing (at initiation "early" or conclusion "late" of procedure) on the postoperative pain levels reported in patients following robot assisted laparoscopic radical prostatectomy (RALP).
研究概览
简要总结
Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).
详细描述
TAP block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. Often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. The idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. More recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (RALP) with promising results. There is a lack of data comparing the benefits of the timing of TAP block, and whether performing this at the initiation versus conclusion of the case provides superior results
This is a prospective, randomized controlled trial of subjects undergoing early versus late TAP block for the management of postoperative pain following RALP. Subjects will be recruited through physician referral from private Urology offices. Potential subjects (patients scheduled for RALP procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area.
Subjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic TAP block. Each patient will only receive one treatment (TAP block) either at the initiation or conclusion of his procedure.
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). Study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be sedated for the procedure and unaware of when the TAP block is administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information.
- •Men ≥ 18 years of age.
- •Pathologically confirmed diagnosis of prostate cancer
- •Scheduled for routine RALP
排除标准
- •Chronic opioid use (daily for >3 months)
- •Weight <40 kilograms
- •Any condition that causes a lack of normal sensation to the abdomen or pelvis
- •Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
研究组 & 干预措施
Early TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port).
干预措施: Early TAP Block (Drug)
Late TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the conclusion of the procedure (immediately preceding removal of the robotic / laparoscopic camera port).
干预措施: Late TAP Block (Drug)
结局指标
主要结局
Compare laparoscopic-guided TAP block timing (at initiation "early" or conclusion "late" of procedure) on the postoperative pain levels reported in patients following robot assisted laparoscopic radical prostatectomy (RALP).
时间窗: 24 hours after RALP
Comparison of patient reported pain scales, based on a score from 0 to 10. Where 0 is no pain and 10 is the worst pain.
次要结局
- Compare the effects of TAP Block timing on total opioid consumption(7 days after RALP with TAP Block)
- Compare the effects of TAP Block timing on hospital length of stay(7 days after RALP with TAP Block)
- Compare the effects of TAP Block timing on return of bowel function(7 days after RALP with TAP Block)
- Compare the effects of TAP Block timing on postoperative nausea/vomiting(7 days after RALP with TAP Block)
- Compare the effects of TAP Block timing on ambulation(7 days after RALP with TAP Block)
- Compare the effects of TAP Block timing on readmission for pain(7 days after RALP with TAP Block)
- Compare the safety and tolerability of laparoscopic TAP block.(7 days after RALP with TAP Block)
研究者
S Mohammad Jafri
Urologist
Corewell Health East