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临床试验/NCT02708017
NCT02708017已完成不适用

The Analgesic Efficacy of Ultrasound Guided Bilateral Subcostal vs. Posterior Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Aga Khan University0 个研究点目标入组 70 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours

研究概览

简要总结

The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy

详细描述

After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives.

Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy

排除标准

  • Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason

结局指标

主要结局

Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours

时间窗: 24 hours

To compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between two groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)

次要结局

  • Mean opioid consumption postoperatively(24hours)
  • Nausea , vomiting and sedation score(24 hours)
  • Surgical outcome(24 hours)
  • Patient satisfaction(24hours)

研究者

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

DR.Karima karam khan

Dr.Karima karam khan

Aga Khan University

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