Efficacy of Transversus Abdominis Plane Block in an Insufflated Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Patient satisfaction
研究概览
简要总结
This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method.
详细描述
Background
Every year 15 million laparoscopic procedures are performed globally, with 4,800,000 or 32% of procedures performed in the U.S. alone. This minimally invasive procedure is one of the most common surgical procedures in the United States. Approximately 350,000 or half of all bilateral tubal sterilizations are performed laparoscopically; almost two-thirds of the 600,000 hysterectomies are performed via laparoscopy. Laparoscopy is also commonly used for diagnostic purposes, and to perform other common procedures such as treatment for endometriosis and lysis of adhesions. During laparoscopic gynecologic surgeries, the surgical team will have the abdomen inflated with pressurized carbon dioxide for surgical visualization purposes which is then released at the end of the surgical procedure. For many laparoscopic procedures, a transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain performed outside the OR, more for logistical ease, traditionally this block is performed outside the operating room setting, in the post-operative period on a non- insufflated abdomen under ultrasound guidance.
Rationale for conducting the research. This study has two major aims; 1) to determine whether post-operative TAP blocks performed in an insufflated abdomen will result in more optimal postoperative pain control compared to TAP blocks performed in the traditional method in a non-insufflated abdomen and 2) to observe if performing the TAP block in a insufflated abdomen will be more clinically efficient to perform than the traditional method performed in a non-insufflated abdomen. The study hypothesis is that the study group receiving the TAP block the insufflated abdomen will have more optimal postoperative pain control, requiring less adjuvant pain medication as compared to the participants receiving the control intervention. Additionally, we hypothesize that the proceduralist will be able to perform a TAP block in less time with and with few attempts in the insufflated compared to the non- insufflated abdomen group due to better visualization of the anatomical planes from insufflation of the abdominal area. The results of this study may add additional clinically effective practice guidelines for both regional anesthesia and acute pain management relating to laparoscopic gynecological procedures. Furthermore, TAP blocks performed under insufflation may provide a viable method for decreasing opioid use and reducing potential opioid dependence in patients following surgical intervention.
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
The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment.
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure.
- •Consent received to receive a TAP block.
排除标准
- •Patients who are not proficient in the English language or cannot consent
- •Patients who have an allergy to local anesthetics (amides)
- •Patients with subcutaneous emphysema
- •Patients whose surgical procedures require incisions above the umbilicus
结局指标
主要结局
Patient satisfaction
时间窗: 24-hours post operative period
Patient satisfaction with analgesia score (0 to 100%)
Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery
时间窗: 0 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Postoperative Opioid Consumption
时间窗: 24 hours post operative period
Patient opioid consumption in the 24 hours post TAP block
Time to perform TAP Block
时间窗: Within 10 minutes of starting procedure.
Time taken to successfully perform the TAP block. Defined as the time from initial placement of ultrasound probe on the skin to the completion of the block on the contralateral side.
TAP block attempts
时间窗: Within 10 minutes of starting procedure.
The number of attempts taken to sucessfully perform the TAP block.
Ease of performing TAP Block-anatomical plane visualization
时间窗: Within 10 minutes of starting procedure
The anatomical planes were clearly visualized and identified. Survey of operator - Likert Score
Ease of performing TAP Block-performance efficacy
时间窗: Within 10 minutes of starting procedure
The approach optimized the efficacy of the block. Survey of operator- Likert score
Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery
时间窗: 4 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery
时间窗: 24 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery
时间窗: 1 hour following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery
时间窗: 2 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
次要结局
未报告次要终点
研究者
Justin Hruska
Principal Investigator
Wayne State University
