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临床试验/NCT03954795
NCT03954795已完成不适用

The Comparison of Analgesic Sparing Effects of Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Transversus Abdominis Plane Block (TAP) in Patients Undergoing Laparoscopic Cholecystectomy

Balikesir University0 个研究点目标入组 75 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
主要终点
Change in postoperative pain scores throughout time evaluated by VAS

研究概览

简要总结

The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and OSTAP in patients undergoing laparoscopic cholecystectomy.

详细描述

Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1: Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was induced and maintained in all patients. At the end of the operation patient controlled analgesia with morphine was applied to all patients.

Pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption and pain scores were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for laparoscopic cholecystectomy
  • ASA status I-II

排除标准

  • Local anesthetic allergy
  • Coagulopathy
  • Infection at procedure site

研究组 & 干预措施

Group 1: TAP Block

Active Comparator

TAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)

干预措施: TAP (Procedure)

Group 2: OSTAP Block

Active Comparator

Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

干预措施: OSTAP (Procedure)

No Block

No Intervention

No interventions

结局指标

主要结局

Change in postoperative pain scores throughout time evaluated by VAS

时间窗: Pain scores will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.

Pain scores are going to be evaluated via VAS score. The VAS score will be scored between 0-10. 0 points is defined as no pain and 10 points is the most severe pain imaginable by the patient. A higher VAS score reflects a poor pain control.

Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.

时间窗: The amount of Morphine demanded by the patient will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.

The amount of morphine demand of the patient measured through morphine delivery by the patient controlled analgesia device

Amount of total intraoperative remifentanil infusion

时间窗: At the end of surgery.

The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozlem Sagir, MD

associated professor

Balikesir University

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