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临床试验/NCT02375100
NCT02375100已完成不适用

Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia

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: 2015年2月最近更新:
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
发起方
入组人数
90
试验地点
1
主要终点
Pain Assessment with Verbal Descriptor Scale (VDS)

研究概览

简要总结

This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. One-third of the patients will receive standard postoperative pain regimen(control group), one-third will receive a transversus abdominis plane block (with ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with ultrasound guidance) in addition to standard postoperative pain regimen. This study is a Randomized prospective open-label controlled study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over 18 years old
  • having ASA (American Society of Anesthesiologists) 1 or 2 physical status score preoperatively
  • not having a neuromuscular disease
  • scheduled for elective single sided inguinal herniorraphy operation

排除标准

  • being under 18 years of age
  • patient refusal
  • having a neuromuscular disease or sensorial neurological deficit covering similar area of effect with peripheral nerve block interventions or the surgical site
  • having ASA 3 or 4 physical status score preoperatively
  • having one of the contraindications to spinal anesthesia and/or to peripheral nerve blocks as listed by NYSORA (New York School of Regional Anesthesia)
  • having emergency surgery or scheduled for bilateral inguinal herniorraphy

研究组 & 干预措施

Intrathecal bupivacaine&analgesics

Active Comparator

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

干预措施: Spinal Anesthesia (Procedure)

Intrathecal bupivacaine&analgesics

Active Comparator

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

干预措施: Bupivacaine %0.5 (hyperbaric) (Drug)

Intrathecal bupivacaine&analgesics

Active Comparator

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

干预措施: 25G Quincke needle (Device)

Intrathecal bupivacaine&analgesics

Active Comparator

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

干预措施: Acetaminophen (Drug)

Intrathecal bupivacaine&analgesics

Active Comparator

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

干预措施: Tramadol (Drug)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Spinal Anesthesia (Procedure)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Transversus Abdominis Plane Block (Procedure)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Bupivacaine %0.5 (hyperbaric) (Drug)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Bupivacaine %0.25 (isobaric) (Drug)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: 25G Quincke needle (Device)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Echogenic Needle with 30° bevel (Device)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Acetaminophen (Drug)

TAP Block with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Tramadol (Drug)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Spinal Anesthesia (Procedure)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Ilioinguinal Nerve Block (Procedure)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Bupivacaine %0.5 (hyperbaric) (Drug)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Bupivacaine %0.25 (isobaric) (Drug)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: 25G Quincke needle (Device)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Echogenic Needle with 30° bevel (Device)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Acetaminophen (Drug)

IlNB with bupivacaine

Experimental

In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

干预措施: Tramadol (Drug)

结局指标

主要结局

Pain Assessment with Verbal Descriptor Scale (VDS)

时间窗: 1st month after surgery

次要结局

  • First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)(whenever in 48 hours after surgery)
  • Additional analgesic requirements(1st month after surgery)
  • Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain))(1st month after surgery)

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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