跳至主要内容
临床试验/CTRI/2024/01/061167
CTRI/2024/01/061167尚未招募2 期

Comparision of efficacy of erector spinae plane block versus conventional pharmacological therapy in successfully alleviating abdominal pain of patients with pancreatitis in an emergency department: A Randomized Control Trial

Department of Emergency Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To assess the efficacy of successful pain relief (more than 50% reduction in pain score by Defense and Veterans Pain Scale(DVPRS) from presentation or DVPRS less than 4 or total

研究概览

简要总结

It is a prospective, open label, randomized control trial of parallel-groups to compare the efficacy of erector spinae plane block versus conventional pharmacological therapy in successfully alleviating abdominal pain of patients with pancreatitis in an Emergency Department. Patients of pancreatitis with Abdominal pain will be examined and history will be taken, patients meeting inclusion criteria will be included in the study after taking consent for the study. Patients meeting any one of the exclusion criteria will be excluded from the study. After that, randomization to different study arm patient will be allcocated, randomization will be done by a pre-formed computer generated randomization table and allocation concealement will be done by SNOSE technique. Our primary objective is to assess the efficacy of successful pain relief (more than 50% reduction in pain score by DVPRS from presentation or DVPRS less than 4 in both arm at one hour in both ESPB arm and conventional pharmacological therapy (CPT) arm. Secondary objectives are to assess pain score assessment at different time interval up to 6 hours or up to 24 hours if patient remains in ED, pain free interval in both arm, timing of rescue therapy, drugs or procedure related adverse events in both arm, reasons for failure of therapy in both arm, efficacy of image acquisition and optimization and interpretation by different performers on Likert scale, patient feedback based on Likert scaling regarding preference of therapy he or she would opt for in next visit.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Adults patients (≥ 18 years of age) who are already diagnosed as acute or recurrent acute pancreatitis, presenting to the emergency department of AIIMS New Delhi within 7 days of onset of abdominal pain with DVPRS ≥
  • Patients willing to give consent.

排除标准

  • Patients with hemodynamic instability
  • Patients having one or more organ dysfunction
  • Patients allergic to drugs
  • Local site infection
  • Spine deformity (both acquired or congenital)
  • Pregnancy
  • Immunosuppressive state
  • Patients with chronic kidney disease, chronic liver disease, congestive heart failure.

结局指标

主要结局

To assess the efficacy of successful pain relief (more than 50% reduction in pain score by Defense and Veterans Pain Scale(DVPRS) from presentation or DVPRS less than 4 or total

时间窗: Primary outcome will be assessed and analysed after six hours of intervention in both ESPB arm | and conventional pharmacological therapy (CPT) arm.

amount of rescue analgesia needed) after six hours of intervention in both ESPB arm

时间窗: Primary outcome will be assessed and analysed after six hours of intervention in both ESPB arm | and conventional pharmacological therapy (CPT) arm.

and conventional pharmacological therapy (CPT) arm.

时间窗: Primary outcome will be assessed and analysed after six hours of intervention in both ESPB arm | and conventional pharmacological therapy (CPT) arm.

次要结局

  • Drugs or procedure related adverse events in both arm(Upto 6 hours after intervention or 24 hours if)
  • Pain score assessment at different time interval (at 1 hour, 6 hours, then every 6(hours up to 24 hours))
  • Pain free interval in both arm: It will be defined as either DVPRS less than 4 or no need of(rescue analgesia.)
  • Timing of rescue therapy in both arm and total cumulative dose of fentanyl as rescue(therapy after 12 and 24 hours)
  • Patient feedback based on Likert scaling regarding preference of therapy he or she(would opt for in next visit)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Satyendra Meena

AIIMS, New Delhi

研究点 (1)

Loading locations...

相似试验