Comparing Erector Spinae Plane (ESP) and Transversus Abdominis Plane (TAP) Block Analgesic Effect After Robotic TAPP Abdominal Hernia Repair: a Single Center, Randomized, Triple-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Highest Visual Analogue Scale
研究概览
简要总结
The Erectore Spinae Plane Block (ESP Block) is a recently described technique for regional anesthesia that has shown promising results in the treatment of pain after thoracic surgery. It involves the injection of local anesthetic behind the musculature of the back.
The investigators intend to compare this technique with a more standardized one, the TAP Block, which involves injection of anesthetic behind the musculature of the abdomen.
50 patients undergoing robotic inguinal hernia repair under general anesthesia will be randomly selected to receive, in addition to general anesthesia, either the ESP block or the TAP block. Patients receiving an ESP Block will also receive an injection of saline solution in the TAP injection site, and the other way around. This will prevent preconceived ideas on either technique to influence the evaluationso of the effect.
Pain scores and consumption of pain medication will be recorded during the 24 hours following the operation to compare the effect of the two techniques.
详细描述
In the recent era of increased awareness towards the risks and complications of opioid treatment, pain management after common surgical interventions by the means of regional anesthesia is of renewed interest for both clinical and logistic reasons, as it is known that good pain management reduces complications and cost associated to surgery.
Regional and local anesthetic techniques after inguinal hernia surgery have been the topic of multiple studies, comparing various infiltrative methods, including wound infiltration, port site infiltration, iliohypogastric and ilioinguinal nerve block, paravertebral and transversus abdominis plane (TAP) block and epidural analgesia. Most methods investigate pain treatment in the setting of open surgery. The progressive evolution towards laparoscopic and robot-assisted methods changes the mechanisms of surgical pain and, with it, the rational for the choice of the analgesic technique adopted. The transversus abdominis plane (TAP) has become a widely used technique and has been demonstrated to be associated to a mild opioid sparing effect, but with inconsistent results.
The erector spinae plane block is a promising technique, recently described and used especially in thoracic surgery. Multiple case reports and studies in pediatrics report it to be a safe and effective method for abdominal surgery as well, but no prospective randomized trials were published to date in the adult population, particularly with regard to laparoscopic or robotic hernia repair. A prospective comparison between the two techniques is therefore needed in this specific context.
Hypothesis and primary objective:
The investigators hypothesize the superiority of the ESP-block to the TAP-block with respect to post-operative pain control after abdominal surgery, leading to a reduction in reserve analgesic consumption.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
According to the randomization arm patients will receive:
- sham US-guided ESP block + US-guided TAP block before laparoscopic hernia repair
- US-guided ESP block + sham US-guided TAP block before laparoscopic hernia repair Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program.
Personnel not directly involved with patient care will prepare a saline solution and a ropivacaine solution which will be allocated respectively to ESP or TAP block according to randomization.
This will allow blinding of patients, care providers and data collectors. Analysis will be done on allocation-concealed data, permitting blinded analysis.
Unbliding will be permitted if by doing so harm to one or more patients can be avoided or treated. After information of one of the principal investigators, specific patient allocation will be retrieved from the randomization program.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Patients over 18 years of age
- •Planned elective unilateral or bilateral robot-assisted TAPP hernia repair, with mesh placement
排除标准
- •Contraindications to ropivacaine or opioids, e.g. known hypersensitivity or allergy
- •Infections at the injection site
- •Coagulopathies or ongoing anticoagulant therapy
- •Concomitant surgery other than inguinal or umbilical hernia repair
- •Pre-operative chronic narcotic usage
- •Known chronic pain syndrome
- •Prior complex abdominal wall reconstruction
- •Frail patients for whom a prolonged sedation can be detrimental
- •Women who are pregnant
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to consent or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
结局指标
主要结局
Highest Visual Analogue Scale
时间窗: Between end of sedation and 6 hours after surgery
0 to 100mm, highest equals to more pain
次要结局
- Visual Analogue Scale score at rest and at movement(1, 3, 6, 12 and 24 hours after surgery)
- Total dose of rescue opioids(in the first 24 hours after surgery)
- Time of first walk after surgery(24 hours)
- Episodes of urinary retention(24 hours)
- Need for anti-nausea medication (dosage, doses and time points)(24 hours)
研究者
Ghielmini Enea
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona