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临床试验/NCT06274307
NCT06274307已完成不适用

Efficacy of Transversus Abdominis Plane Block in an Insufflated Abdomen

Justin Hruska4 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2023年6月22日最近更新:
适应症

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

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

发起方
Justin Hruska
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Justin Hruska

Principal Investigator

Wayne State University

研究点 (4)

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