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临床试验/NCT03126084
NCT03126084已完成4 期

Comparison of Postoperative Analgesic Effects of Transversus Abdominis Plane Block and Quadratus Lumborum Block Type 2

Bozyaka Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

This study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will receive routine intravenous analgesic regimen. In addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. One-third of the patients will not receive any blocks and will constitute the control group

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)

入排标准

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

入选标准

  • Patients who are over 18 years of age
  • Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques
  • Patients who are in ASA's physical status score group 1 or 2

排除标准

  • Patients who are younger than 18 years of age
  • Patients who have severe stenotic heart diseases
  • Patients who have bleeding diathesis
  • Patients who have true allergies to local anesthetics
  • Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques

研究组 & 干预措施

TAP

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Acetaminophen (Drug)

TAP

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: 0.25% Bupivacaine (Drug)

TAP

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: 0.5% Bupivacaine+Glucose (Drug)

TAP

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Tramadol HCl (Drug)

TAP

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Inguinal Hernia Repair (Procedure)

QLB2

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Acetaminophen (Drug)

QLB2

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: 0.5% Bupivacaine+Glucose (Drug)

QLB2

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Tramadol HCl (Drug)

QLB2

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Inguinal Hernia Repair (Procedure)

QLB2

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: 0.25% Bupivacaine (Drug)

CONT

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Acetaminophen (Drug)

CONT

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: 0.5% Bupivacaine+Glucose (Drug)

CONT

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Tramadol HCl (Drug)

CONT

Active Comparator

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

干预措施: Inguinal Hernia Repair (Procedure)

结局指标

主要结局

Pain Intensity

时间窗: 48 hours after surgery

Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

次要结局

未报告次要终点

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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