跳至主要内容
临床试验/NCT04809532
NCT04809532Unknown不适用

Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Cesarean Section: a Randomized Study.

Armed Forces Hospital, Pakistan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
postoperative consumption of opioids

研究概览

简要总结

Objective: To compare Trans Abdominis Plane block in providing post cesarean analgesia with control group, in terms of mean postoperative use of Opioids.

Study design: Randomized controlled trial. Place and duration Department of Anesthesiology, Combined Military Hospital, Sargodha, 25th February 2021 to 25th April 2021.

Materials and methods: A total of 60 female patients, who are planned to undergo elective c section and aged between 20-45 will be selected randomly and divided into two groups ( A and B) with 30pts each group. In Group A, at the end of surgery, TAP block will be given with 20ml of 0.25%bupvicaine via ultrasound guided sub-costal approach on both sides of midline. Time of TAP block will be recorded as time 0. Our outcomes will be: mean postoperative consumption of opioids and VAS score within 24hrs of surgery. Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery. P value <0.05 will be considered statistically significant.

详细描述

Analgesic efficacy of trans abdominis plane block in women undergoing Cesarean section: a randomized controlled trial.

Introduction:

Cesarean section is considered as one of the most commonly performed surgery worldwide. Based on the data from 121 countries, the trend analysis showed that between 1990 and 2014, the global average CS rate increased 12.4% (from 6.7% to 19.1%) with an average annual rate of increase of 4.4%.Its incidence in 2010 and 2013 was 41.9% and 48% respectively which was contrary to the rate of C/S recommended by the World Health Organization as fifteen percent for year 2014 .Just like all other major abdominal surgeries, c section comes with severe postoperative pain ,which if not managed properly can not only leads to prolonged immobility and its associated adverse effects but can also affect mother-baby bonding, care of baby, breast feeding and may lead to chronic pain and post-partum depression Multiple modalities are available for managing this post cesarean pain. Mostly systemic opioids are used but they are often associated with a number of undesirable side effects such as nausea, vomiting, pruritus, constipation, and respiratory depression,sedation.Other than opoids, systemic NSAIDS such as ketorolac, acetoaminophen are also used but alone they may be insufficient to treat post cesarean pain. Other analgesic options currently being used include local anesthetic techniques (local anesthetic infiltration, neuraxial blocks) acetaminophen , cyclooxygenase-2-specific inhibitors as well as analgesic adjuncts such as steroids, ketamine and α-2 agonists such as clonidine.

Neruoaxial anesthesia such as lumbar or thoracic epidurals are also used but because of constant and strict monitoring ,they are not considered economical for patients as well as for hospitals. With recent advancements in regional anesthesia, some regional blocks are now being utilized for postoperative pain relief in c sections such as TAP blocks but their use is still limited because of nonavailability of sufficient data.

Transversus abdominis plane (TAP) block provides analgesia by blocking nerves in anterior abdominal wall through introduction of a long-acting local anesthetic solution between the internal oblique and transversus abdominis muscles. Its use in c section is still limited ,but is considerd to be increased in future as is now been shown by several studies .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 20 and 45 years
  • Elective cesarean
  • Fit to undergo surgery under spinal anesthesia

排除标准

  • Patients who will have
  • Any contraindication to spinal anesthesia
  • ASA class III and IV
  • Known Allergic to local anesthetic
  • Eclampsia
  • Placenta accreta/percretra

研究组 & 干预措施

Group A

Experimental

Transverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery

干预措施: Transverse abdominis plane (TAP) block (Procedure)

Group A

Experimental

Transverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery

干预措施: Bupivacain (Drug)

Group A

Experimental

Transverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery

干预措施: Tramadol (Drug)

结局指标

主要结局

postoperative consumption of opioids

时间窗: 24hours after surgery

questionnaire will be filled 24hours after the surgery by trainee anesthesia and he/she will document the total consumption of intravenous tramadol after surgery

次要结局

未报告次要终点

研究者

发起方
Armed Forces Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

arshad khushdil

Principal Investigator

Armed Forces Hospital, Pakistan

研究点 (2)

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