Laparoscopic-assisted Transversus Abdominis Plane (TAP) Block for Laparoscopic Total Extra Peritoneal (TEP) Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
A newly developed technique of TAP block solely performed by surgeons will be used for postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the periportal wound infiltration in controlling the postoperative pain.
详细描述
Hypothesis:
A newly developed technique of TAP block solely performed by surgeons will be used for postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the periportal wound infiltration in controlling the postoperative pain.
Significance of the study:
Postoperative pain control is very important in day case surgery. Use of local anaesthetics has a significant role in this scenario.
No study to date examines the use of laparoscopically delivered TAP blocks in TEP hernia repairs. This technique is more reliable, solely performed by surgeons, and is supposed to replace the ultrasound-guided method. The latter is time-consuming, need ultrasound skills and is usually done by anaesthetists. Previous reports have shown advantage for the ultrasound-guided TAP block in controlling postoperative pain for several types of surgery. Our previous study for use of laparoscopically delivered TAP block in Laparoscopic Cholecystectomy has shown significant advantage in pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive ASA grade I-II- III patients undergoing elective unilateral laparoscopic total extra peritoneal (TEP) Inguinal hernia repair
- •Age 18 - 80 yrs, including those who are having recurrent inguinal hernia repair.
排除标准
- •ASA grade IV, V
- •Bilateral inguinal hernia repair
- •BMI > 40 kg/m2
- •Converted to open procedures.
- •Conversion to Transabdominal preperitoneal (TAPP) repair
- •Coagulopathy.
- •Allergy to Bupivacaine.
- •Diagnosis of "chronic pain syndrome".
- •Known alcohol or substance abuse within the last 6 months.
- •Daily Opioid intake.
研究组 & 干预措施
TAP block group
This group will receive 30 ml of 0.25% Bupivacine given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine.
They will also receive normal saline injections at port sites, which will be injected before the ports are inserted. 15 ml of normal saline will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports.
干预措施: TAP Block Group (Drug)
Peri-Portal block Group
They will receive 0.5% Bupivacaine injections at port sites, which will be injected before the ports are inserted. 15 ml of 0.5% Bupivacaine will be divided in aliquots of 7, 4 and 4 ml. 7 ml will be injected at sub-umblical port side and 4 ml each at the site of other two ports.
This group will also receive 30 ml of Normal Saline Injection given as Transversus Abdominus Plane Block under direct Laparascopic view. The TAP block will be injected in the angle of Petit above the anterior superior iliac supine.
干预措施: Peri-Portal Block Group (Drug)
结局指标
主要结局
Pain Scores
时间窗: Within 24 hours post surgery
Numerical Analogue score for pain will be recorded at 1, 3, 6 and 24 hours post surgery
次要结局
- Post operative nausea or vomiting(24 hours post operative period)
- Total opioid usage(within 24 hours perioperative period)
研究者
Asif Khan
Registrar, General Surgery
Mayo General Hospital, Ireland