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临床试验/CTRI/2024/01/060995
CTRI/2024/01/060995
进行中(未招募)
Phase 3 4

A prospective randomised trial comparing postoperative pain relief between bilateral external oblique intercostal plane block and intravenous morphine in patients after upper abdominal surgeries

Nivedhyaa1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年1月8日最近更新:

概览

阶段
Phase 3 4
状态
进行中(未招募)
发起方
Nivedhyaa
入组人数
66
试验地点
1
主要终点
Mean requirement of intravenous morphine in either groups as rescue analgesic

概览

简要总结

This is a study for comparing postoperative pain relief between the external oblique intercostal plane block and intravenous morphine in upper abdominal surgeries when the patient has a pain score greater than 3.Patients are generally treated with epidural drugs for pain relief.Inspite of that if they have pain in the postoperative period they will be randomised and given either the block or intravenous morphine.Then the difference in pain scores before and after the block will be seen

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • All patients who report moderate to severe upper abdominal pain, defined as a pain score on the numerical rating scale (NRS) of 0-10 as 4 or above for the first three days (POD 0,1,2 and 3) at rest or due to movement or spirometry, in the postoperative period will be included both elective and emergency surgeries 2.Patient who have given informed consent for the procedure.
  • 3.Age of 18 and above 4, Surgeries with upper abdominal incisions including gastric surgeries, splenectomy, cholecystectomy, hepatectomy will be included for the study.

排除标准

  • 1.renal diseases with elevated serum creatinine level more than 1.5mg% 2.Local skin site infection at the site of epidural or at the site of the EOIPB as identified before surgery 3.Patient refusal to give consent for epidural or blocks 4.History of known allergies to local anaesthetics or morphine .Suspected bowel obstruction : in this case we cannot use opioids 6.Patient would get discharged in less than 24 hours.
  • 7.Drowsy patient who cannot tell about the pain score appropriately 8.Patients in whom epidural catheter will not be placed (as known preoperatively due to low platelet count or altered coagulation profile) 9.Patients who have been treated with tablet morphine in the preoperative period for pain.

结局指标

主要结局

Mean requirement of intravenous morphine in either groups as rescue analgesic

时间窗: Mean requirement of intravenous morphine in either groups as rescue analgesic upto 24 hours

次要结局

  • Pain Intensity Difference(Side Effects)

研究者

发起方
Nivedhyaa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nivedhyaa S

Cancer Institute (WIA),Adyar

研究点 (1)

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