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临床试验/NCT06736392
NCT06736392尚未招募2 期

Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Postoperative Analgesia During Spinal Anesthesia in Hip Replacement Surgeries, a Randomized Controlled Study

Assiut University0 个研究点目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
主要终点
total amount of postoperative morphine consumption in the first 24h postoperative.

研究概览

简要总结

Our aim will be to investigate the efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for postoperative analgesia in hip replacement surgeries.

  • Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
  • Our secondary outcome of the study: postoperative analgesia assessed by pain score (by Visual Analog Scale)

详细描述

Effective postoperative pain management is essential for optimizing recovery and patient outcomes following hip surgeries.

The pericapsular nerve group (PENG) block has gained attention as a regional anesthesia technique that provides targeted analgesia to the hip joint and surrounding structures, reducing opioid consumption and avoiding its side effects as nausea, vomiting, constipation, itching, rash, addiction, urinary retention, respiratory depression especially at higher doses By delivering local anesthetics close to the genicular branches of the femoral nerve, the pericapsular nerve group (PENG) block offers several advantages as part of multimodal analgesia in comparison to other nerve blocks used for hip surgeries, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB) as better pain relief for capsular structures with minimal motor blockade, lower risk of complications and reducing need for opioids making it particularly suitable for orthopedic procedures.

Traditionally, local anesthetics such as bupivacaine have been used in the pericapsular nerve group (PENG) block to achieve effective analgesia. However, despite its long acting properties, their duration of action is typically limited to 6 to 12 hours depending on factors like the concentration, dose and individual patient characteristics and the quality of analgesia may diminish as the anesthetic effect wears off, potentially necessitating additional analgesic interventions or systemic opioids to maintain pain control.

Therefore, there is a growing interest in exploring adjuvants that can enhance the efficacy and duration of pain relief without compromising safety such as Dexmedetomidine, Clonidine, and Dexamethasone.

Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, has emerged as a promising adjuvant in prolonging the duration and improving the quality of peripheral nerve blocks through its potent analgesic and sedative effects, by binding to its receptors, reducing the release of norepinephrine and inhibiting pain transmission , by this mechanism not only enhances sensory blockade but also provides effective postoperative analgesia with minimal motor impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 years to 90 years
  • Gender : both males and females
  • BMI less than 35 kg/m2
  • Patients with American society of anesthesiologists (ASA) classification class I , II or III
  • Patients scheduled for total or partial hip replacement surgery under spinal anesthesia

排除标准

  • Patient declining to give written informed consent
  • Patient with infection at the site of injection
  • Patient with coagulopathy
  • Patients with known allergy to used medications.
  • Psychiatric disorder

研究组 & 干预措施

group C

Active Comparator

(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%

干预措施: Ultrasound guided Pericapsular Nerve Group Block (Procedure)

group C

Active Comparator

(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%

干预措施: Isobaric Bupivacaine 0. 25% (Drug)

group C

Active Comparator

(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%

干预措施: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz) (Device)

group C

Active Comparator

(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%

干预措施: a standard echogenic 20-22 gauge 100mm needle (Device)

group D

Active Comparator

Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%

干预措施: Ultrasound guided Pericapsular Nerve Group Block (Procedure)

group D

Active Comparator

Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%

干预措施: 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine (Drug)

group D

Active Comparator

Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%

干预措施: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz) (Device)

group D

Active Comparator

Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%

干预措施: a standard echogenic 20-22 gauge 100mm needle (Device)

结局指标

主要结局

total amount of postoperative morphine consumption in the first 24h postoperative.

时间窗: within the first 24 hours postoperatively

次要结局

  • the intensity of postoperative pain assessed by the Visual Analog Scale for pain(within the first 24 hours postoperatively)

研究者

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

Mahmoud Mamdooh Wardany

DOCTOR

Assiut University

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