跳至主要内容
临床试验/NCT04462510
NCT04462510已完成不适用

A Comparison Between Ultrasound Guided Ilioinguial/Iliohyphogastic Nerves Block and Infiltration of Wound With Ropivacaine on Post-Operative Pain After Open Repair of Unilateral Inguinal Hernia in Adults: A Randomized Controlled Trial

Aga Khan University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain score

研究概览

简要总结

This study was conducted to assess the postoperative painscores in patients undergoing open inguinal hernia repair between two groups receiving either U/S guided ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves blocks and wound infiltration) was measured alongwith comparison of opioid use between the two groups over 24 hours postoperatively was made. Patient satisfaction between the two groups was also assessed by the Likert scale.

详细描述

Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal analgesia is recommended to overcome this issue. Therefore this randomized controlled trial was conducted to compare the analgesic efficacy of ultrasound guided Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.

This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised controlled trial conducted from March 2019 to October 2019. 60 participants for elective unilateral open inguinal hernia repair were included. Patients were randomly allocated (30 each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25% Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site to provide postoperative analgesia. Postoperative pain at rest (static) and on movement (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol consumption and time for first tramadol requirement was noted.

In addition complications related to IHG block and LA infiltration were observed.Patient satisfaction was also gauged by the LIKERT scale in the questionairre.

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
Single (Participant)

盲法说明

The patients were randomized using computer generated numbers and did not know which group did they fall in

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients between the ages of 18-75 years, scheduled for unilateral open primary hernia repair electively
  • American society of Anaesthesiologists(ASA) standard I to IV

排除标准

  • BMI below 18 or above 35 kg/m2
  • Local anesthetic allergy
  • Pregnancy
  • Infection at injection site
  • Coagulation disorders
  • Contraindication to any drug used in the standard anesthesia regimen

结局指标

主要结局

Pain score

时间窗: This was measured 24 hours after the surgery

Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

次要结局

  • Tramadol consumption(This was measured at 0,2,6,12 and 24 hours after the surgery)
  • Patient satisfaction(This was assessed at the end of 24 hours post operatively.)

研究者

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

Summaiya Ahsan Ali

Principal Investigator

Aga Khan University

研究点 (2)

Loading locations...

相似试验