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临床试验/CTRI/2024/10/075620
CTRI/2024/10/075620尚未招募3 期

A comparative study of dexmedetomidine and butorphanol as an adjuvant in ultrasound-guided erector spinae plane block for perioperative analgesia in children undergoing thoracoabdominal surgeries

Post graduate institute of child health1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
duration of analgesia i.e. time of block placement to the time of administration of first rescue analgesia

研究概览

简要总结

Earlier beliefs held that children were incapable of feeling pain but now the paediatric pain management has advanced significantly. It is widely recognised that proper care in the paediatric intensive care unit (PICU)

and pain management are essential. Pain-related stress in the paediatric population might affect emotional and neurocognitive outcomes, as well as cause pain sensitivity in childhood. Regional analgesia is one

method of delivering analgesia without risking narcotic dependence. It has been demonstrated that, the erector spinae plane block (ESPB) can reduce pain during thoracic and abdominal procedures.    Use of a

variety of adjuvant medications in conjunction with local anaesthetics, including opioids, dexmedetomidine, clonidine, dexamethasone, and butorphanol, to increase the   duration as well as intensity of analgesia.

The present study aims to compare the effectiveness of dexmedetomidine and butorphanol in reducing post-operative pain in children having thoraco-abdominal procedures, when used as an adjuvant with isobaric

bupivacaine 0.25%, in erector spinae plane block.

HYPOTHESIS -

•Through this study, I would hypothesize that injection dexmedetomidine is better adjuvant in ESPB than injection butorphanol as it increases the time of analgesia of the patient perioperatively.

AIMS AND OBJECTIVES -

•The aim of this study is to compare dexmedetomidine and butorphanol as an adjuvant along with bupivacaine in ultrasound-guided erector spinae plane block for perioperative analgesia in children undergoing thoracoabdominal surgeries.

•PRIMARY OUTCOME -

1.Pain score at predefined time points following surgery for upto 24 hours.

•

•SECONDARY OUTCOME –

1.Timing of rescue analgesia.

2.Haemodynamic stability

AIMS AND OBJECTIVES

Following approval by the Departmental Protocol Committee, Department of Paediatric Anaesthesia, and the Institutional Ethics Committee, Postgraduate Institute of Child Health (PGICH), Noida, the present study wouldbe conducted in the institution on paediatric patients undergoing open thoracic and abdominal surgeries. It is a randomized controlled study. Informed written consent will be taken from the parents/guardians.

Inclusion Criteria:

1.     Age: 1 year - 18 years

2.     ASA I and II patients of either sex

3.     Elective thoracic and abdominal surgery (such as – decortication, chest wall abscess drainage, herniotomy, exploratory laparotomy etc.)

Exclusion Criteria

1.     Evidence of coagulopathy or thrombocytopenia

2.     History of bleeding or clotting disorders

3.     Local infection

4.     Allergy to drugs used in study

5.     Intellectual disability

6.     Chronic pain disorder

7.     On chemotherapy

METHODOLOGY

All children would be kept nil per oral before surgery as per standard ASA guidelines. The intravenous cannula would be secured in the ward before the patient is shifted to the operating room on the

morning of surgery. Premedicate the child with intravenous midazolam 0.1 mg/kg, glycopyrrolate 4mcg/kg, ketamine 0.5 mg/kg. Transfer to the     operating room, electrocardiography, non-invasive

blood pressure, and pulse oximetry would be connected. The baseline preoperative parameters recorded. All patients will be randomized to one of two groups using computer generated random

numbers and a 1:1 allocation ratio. The primary investigator performing the block and the investigator analysing the data will be blinded to the group allocation. After induction, patient will be placed in

lateral position to apply ESPB. An assistant, who will be neither involved in the study nor will be participating in the perioperative period or the postoperative follow-up, will prepare study drugs.

Group A will receive injection 0.25% bupivacaine, single shot, 0.5ml/kg with 1 mcg/kg dexmedetomidine and Group B will receive injection 0.25% bupivacaine, single shot, 0.5ml/kg with 25

mcg/kg  butorphanol deep to the erector spinae muscle adjacent to transverse processes. After the block, the patient of either group will be monitored for oxygen saturation, tachycardia, hypertension

and end tidal carbon dioxide every 15 minutes. If pain persists rescue analgesia in the form of Injection paracetamol 15mg/kg will be administered. The time duration and the time of the block given till

the first dose of rescue analgesia will be noted. On arrival in the post anaesthesia care unit (PACU), oxygen saturation (SpO2), Heart rate (HR), Mean blood pressure (MBP), end tidal carbon dioxide

(EtCO2) and age appropriate scoring will be done. FLACC scoring (<=10 years) and VAS score (>10 years) immediately after the postoperative period once the patient is awake, then at 15 minutes, at

30 minutes, 60 minutes, 90 minutes and 120 minutes, 4 hourly up to 24 hours. Duration of analgesia, requirement of rescue analgesia usage and side effects if any will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • Age: 1 year.
  • ASA I and II patients of either sex
  • Elective thoracic and abdominal surgery.

排除标准

  • Evidence of coagulopathy or thrombocytopenia
  • History of bleeding or clotting disorders
  • Local infection
  • Allergy to drugs used in study
  • Intellectual disability
  • Chronic pain disorder
  • On chemotherapy.

结局指标

主要结局

duration of analgesia i.e. time of block placement to the time of administration of first rescue analgesia

时间窗: upto 24 HOURS

次要结局

  • 1. Pain score at predefined time points following surgery for upto 24 hours
  • haemodynamic stability(intraoperatively - every 15mins)

研究者

发起方
Post graduate institute of child health
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shambhavi Sharma

Postgraduate Institute of Child Health

研究点 (1)

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