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临床试验/NCT05552391
NCT05552391已完成4 期

Dexametomedine Versus Ketamine as an Adjuvant in Ultrasound Guided Erector Spinae Block for Perioperative Thoracotomy Pain Control in Pediatrics Cardiothoracic Surgeries: A Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
the duration of analgesia

研究概览

简要总结

A double-blind randomized control study to compare the efficacy of dexmedetomidine versus ketamine as an adjuvant in combination with bupivacaine ultrasound-guided ESP block in patients scheduled for cardiothoracic surgeries with thoracotomy incision.

详细描述

Following approval from research and ethics committee ,preoperative preparation, and induction of anesthesia Patients will be allocated to three groups according to the type of drug injected.

Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).

Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).

Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).

Unilateral Ultrasound-guided erector spinae block will be applied in both groups after the induction of anaesthesia. All patients will be tilted onto their left side (lateral position). while the ultrasound-guide unilateral erector spinae block will be performed under completely aseptic conditions. The anatomy will be examined by ultrasonography at 5-6Hz with a35 mm linear probe and a SonoSite M-turbo system (Fujifilm SonoSite, Inc., USA). a 22 g bevel needle will be advanced in a cephalad to caudad direction until the tip of the needle reach' the plane deep to the erector spinae muscle and immediately lateral to the transverse process. Once confirmed, after careful aspiration to demonstrate the absence of air or blood. An injection in this plane permitted the block to impact both the dorsal and ventral rami as they exited from the thoracic spine to innervate the chest wall. the block permits a diminished sensation spanning the T3-T10 dermatome levels. confirming the correct tissue plane by hydro-dissection.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • age from 3 to 36 months
  • weight >5 kg.
  • gender both males and females
  • cardiothoracic surgeries with thoracotomy incision.

排除标准

  • 1 Skin erosions , hematomas or infection at or near the injection site.
  • coagulopathy,
  • History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.

研究组 & 干预措施

bupivacaine

Placebo Comparator

Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).

干预措施: Bupivacaine (Drug)

bupivacaine - ketamine

Active Comparator

Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).

干预措施: Bupivacaine (Drug)

bupivacaine - ketamine

Active Comparator

Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).

干预措施: Ketamine Hydrochloride (Drug)

bupivacaine - Dexametomedine

Active Comparator

Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).

干预措施: Bupivacaine (Drug)

bupivacaine - Dexametomedine

Active Comparator

Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).

干预措施: Dexmedetomidine Hydrochloride (Drug)

结局指标

主要结局

the duration of analgesia

时间窗: immediately at the end of pediatric cardiac operation

the duration of analgesia from block start time (time of LA injection) to block end time at which OPS score 4 or more) was recorded.

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Mohamed Elhaddad

Lecturer of Anesthesia, ICU and Pain managment

Kasr El Aini Hospital

研究点 (1)

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