Evaluating Optimal Perioperative Pain Management: A Prospective Randomized Control Trial of Laparoscopic Transversus Abdominis Plane Block With Local Anesthetic, Laparoscopic Transversus Abdominis Plane Block Alone, and Local Anesthetic Alone in Minimally Invasive Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain Score
研究概览
简要总结
This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered "Research" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery:
- Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA)
- Laparoscopic Transversus Abdominis Plane Block (LapTAP) only
- Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.
详细描述
Traditional pain management strategies have heavily relied on the use of Local Anesthesia (LA). Laparoscopic Transversus Abdominis Plane block (LapTAP) has emerged as a new approach for postoperative pain control following minimally invasive surgery, promising enhanced pain control in comparison with traditional approaches. Preliminary investigations into LapTAP have shown promise, yet there remains a significant gap in comparative effectiveness research, especially juxtaposed against the more traditional LA. We propose a comprehensive three-arm superiority trial evaluating LapTAP in conjunction with LA, LapTAP alone, and LA alone. We intend to scrutinize the efficacy of each modality in managing postoperative pain specific to minimally invasive oncologic surgery. Findings from this trial will be used to refine clinical protocols, improve patient outcomes, and potentially standardize care in postoperative pain management for minimally invasive oncologic procedures.
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)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age ≥ 18 - 89
- •Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
- •Patients who have provided informed consent to participate in the study.
- •Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
- •Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
- •Patients able to understand and self-report pain using the designated pain Visual Analog Scale
排除标准
- •Patients age less than 18 or ≥ 90
- •Pre-existing hepatic dysfunction, cirrhosis
- •Patients with an ASA classification of IV or higher.
- •Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
- •Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
- •Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
- •Patients unable to understand the language in which consent and study-related information are provided (The study and the study-related information will be in the English Language)..
- •Patients who have undergone major surgery within the last 6 months.
- •Female patients who are pregnant.
- •Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.
结局指标
主要结局
Pain Score
时间窗: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week)
Pain will be measured in the post anesthesia care unit (PACU) using Visual Analog Scale. Pain will be scored from zero to ten, with zero being no pain at all and ten being unbearable pain.
次要结局
- Opioid Consumption(up to 24 hours post surgery)
- Recovery Analgesic Time(up to 24 hours post surgery)
- Adverse Event(s) Frequency(immediately post surgery up through discharge (on average of 1 week))
- Adverse Event(s) Severity(immediately post surgery up through discharge (on average of 1 week))
- Patient Satisfaction with Pain Management(At discharge (on average of 1 week))
研究者
Casey Allen, MD
Assistant Professor, Surgical Oncologist
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)