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临床试验/NCT02707250
NCT02707250Unknown2 期

Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy

Iuliu Hatieganu University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
120
试验地点
1
主要终点
Pain Scores

研究概览

简要总结

Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.

详细描述

Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.

The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .

Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .

Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, 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

  • American Society of Anaesthesiologists (ASA) I-II
  • Age over 18years old
  • patients scheduled elective laparoscopic cholecystectomy

排除标准

  • Open cholecystectomy - excluded due to increased levels of pain in open procedures
  • Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  • Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
  • Allergy or contraindication to any of the study medications or anesthetic agents
  • Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  • Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  • Pregnancy
  • Prisoners
  • Patient or surgeon refusal

研究组 & 干预措施

Placebo

Placebo Comparator

Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h

干预措施: Placebo (Drug)

Bupivacaine

Active Comparator

Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h

干预措施: Bupivacaine (Drug)

Pethidine

Active Comparator

Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h

干预措施: Pethidine (Drug)

Pethidine Local Infiltration (L.I.)

Active Comparator

Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1%

干预措施: Pethidine Local Infiltration (L.I) (Drug)

结局指标

主要结局

Pain Scores

时间窗: Recorded 24 hours postoperative

This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.

次要结局

  • Side effects(Recorded in the first 24 hours postoperative)
  • Intraoperative fentanyl consumption(0-4 hours)
  • Time to first opioid administration in Post Anesthetic Care Unit(0-4 hours postoperative)
  • Cumulative opioid consumption(Recorded in the first 24 hours perioperative period)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Breazu Caius Mihai

Dr.Breazu Caius Mihai MD

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (1)

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