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临床试验/NCT06950502
NCT06950502已完成不适用

Comparison of the Effects of Bilateral Transversus Abdominis Plane Block and Bilateral Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Midline Laparotomy

Ankara University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively

研究概览

简要总结

Midline incisions provide easy, rapid and excellent exposure of the abdominal cavity and are particularly used for complex, diagnostic or emergency procedures.

However, midline incisions transect the nerve fibers passing in the mediocaudal direction of the abdominal wall, which causes more postoperative pain than other incisions.

Postoperative pain and delayed return of bowel function are thought to be the main factors that prevent early recovery and discharge.

or surgical procedures where parietal pain is the main component of postoperative pain, TAPB can be used as a simple and effective analgesic technique with the added advantage of preserved motor and bladder function.

Quadratus lumborum block can be used as an analgesic technique in all surgeries such as proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy and colectomy.

Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively, early postoperative pain intensity, time to first rescue analgesic requirement, nausea, vomiting and pruritus.

To evaluate this hypothesis, we compared TAPB and QLB in a prospective, randomized, single-center clinical study. The primary endpoint of our study was the comparison of total morphine consumption in the first 24 hours postoperatively.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Laparotomy with midline incision
  • •General anesthesia will be applied
  • •18-70 years old
  • •BMI of 18-30 kg/m2
  • •Without cognitive impairment
  • •Patients who approved the informed consent form

排除标准

  • •Under 18 years old
  • •Over 70 years old
  • •ASA 4 and above
  • •Cognitive impairment
  • •İlliteracy
  • •Vision and hearing problem
  • •Infection at the injection site
  • •Coagulopathy
  • •Peripheral neuropathy
  • •Local anesthetic allergy
  • •Patients who do not want to be included in the study

研究组 & 干预措施

Quadratus Lumborum Group (QLB)

Active Comparator

Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end. The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles. Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.

干预措施: Quadratus Lumborum Block (QLB) (Procedure)

Quadratus Lumborum Group (QLB)

Active Comparator

Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end. The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles. Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.

干预措施: quadratus lumborum block using bupivacaine (Drug)

Transversus Abdominis Plane Group (TAPB)

Active Comparator

Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall. After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively. A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.

干预措施: transversus abdominis plane block (Procedure)

Transversus Abdominis Plane Group (TAPB)

Active Comparator

Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall. After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively. A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.

干预措施: transversus abdominis plane block using bupivacaine (Drug)

结局指标

主要结局

Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively

时间窗: Within 24 hours after surgery

All patients were extubated after the block was performed. All patients were given 1 mg bolus 10 min lock time IV morphine (Morphine Hydrochloride, OSEL Drug) connected to the PCA device (BodyGuard 575i Pain Manager, TARMED). If the morphine given with the PCA device was not sufficient as an analgesic, patients were given 1 gr IV paracetamol infusion (the dose was adjusted so that the paracetamol dose did not exceed a maximum of 4 grams per day). If the VAS was still \>4 at 1 hour after paracetamol, the patient was administered 50 mg IV dexketoprofen (NSAID) (the dexketoprofen dose was adjusted to a maximum of 150 milligrams per day).he amount of opioids used and requested by the patients was recorded as the amount of PCA medication at the 15th minute, 2nd, 4th, 8th, 12th, 16th and 24th hours, as how much opioids they requested or used at the specified time intervals. For example, the amount of opioid used between the 15th minute and the 2nd hour was recorded at the 2nd hour.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Asik

Research Asistant

Ankara University

研究点 (1)

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