The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Acute postoperative pain 4h
研究概览
简要总结
The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair.
详细描述
Inguinal hernia repair is one of the most common elective interventions in general surgery. Approximately 20 million inguinal hernia repairs are performed worldwide every year. Laparo-endoscopic techniques provide faster recovery times, lower chronic pain risk and are cost effective compared to open one.
Nevertheless, laparoscopic inguinal hernia repair can result in moderate to severe pain in the early postoperative period, interfering the time of returning to normal activity in a substantial quantity of patients. To reduce pain and to accelerate recovery, local and regional anesthetics has been successfully implemented into the daily routine of abdominal surgeries.
Recent systematic reviews have shown that TAP block can reduce analgetic consumption and acute pain scores after inguinal hernia repair. However, most included studies were conducted on patients with open hernia surgery or total extra peritoneal (TEP) inguinal hernia repair. Some studies showed the benefit of TAP block for early pain control following TAPP. Most of them were retrospective, some conducted with exclusion of obese or comorbid patients, some in mixed groups without separating patients with TAPP and TEP.
Thus, the evidence of TAP block efficiency prior to hernia repair in TAPP technique are of low quality.
Chronic postoperative inguinal pain (CPIP) develops in up to 6% of patients after TAPP. Several studies have found that intense acute postoperative pain is a risk factor for CPIP after IHR. The investigators hypothesize, that preemptive TAP block temporary stops nociception and central sensitization from the surgical site thus reduce acute postoperative pain that theoretically provoke reducing the incidence of CPIP following IHR. Two studies suggest that TAP block may influence the incidence of CPIP after TAPP. Considering the retrospective study design of both and the insufficient sample size further randomized clinical trials are mandatory to estimate this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Patients with unilateral primary inguinal hernia who are scheduled for elective Transabdominal preperitoneal inguinal hernia repair (TAPP)
- •Signed Informed consent to participation
- •ASA I-III
- •BMI ≤35 kg/m2
- •Non-inclusion Criteria:
- •Inguinoscrotal hernia (hernia passing through the entrance to the scrotum)
- •Previously diagnosed mental disorders
- •Patients receiving psychotropic drugs and drugs affecting adrenal cortex function (estrogens and systemic glucocorticoids)
- •Language barrier
排除标准
- •Deviations during the operation/anesthesia that required transfer to the intensive care unit or conversion to open surgery
- •Refusal to participate
结局指标
主要结局
Acute postoperative pain 4h
时间窗: 4±1 hours postop
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
次要结局
- Concentration of serum cortisol(At 8 am on the day of surgery, 4±1 hours postop)
- Acute postoperative pain 24h(24±3 hours postop)
- Number of Participants with chronic pain(Postoperative 90 (±3) days)
- Acute postoperative pain 2h(2±1 hours postop)
- Acute postoperative pain 6h(6±1 hours postop)
- Patient satisfaction score(Postoperative 30 (±3) days)
- Number of Participants meeting discharge criteria(6±1 hours postop)
- Analgetic consumption (dose quantity)(24 hours postop)
- Length of stay(From date of hospitalization until the date of discharge)
- Number of Participants with postoperative complications(Postoperative 30 (±3) days)
- Number of Participants with recurrence(After 90 days)
研究者
Taras V. Nechay
MD, Professor
Pirogov Russian National Research Medical University