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临床试验/CTRI/2026/02/102984
CTRI/2026/02/102984尚未招募4 期

A Randomized Clinical Trial Evaluating Ultrasound-Guided Pericapsular Nerve Block (PENG) with Dexmedetomidine-Adjuvanted Ropivacaine Versus Plain Ropivacaine for Prolonged Pain Relief in Hip Surgery Patients

Uttar Pradesh university of Medical Sciences1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
102
试验地点
1

研究概览

简要总结

This prospective randomized controlled study includes 60 patients aged 18–75 years, belonging to ASA physical status I–III, scheduled for elective hip surgery. After institutional ethical committee approval and obtaining written informed consent, patients will be randomized using a computer-generated random table with concealed envelope technique into two groups: Group DR (n=30) receiving ultrasound-guided PENG block with 20 ml of 0.25% ropivacaine plus dexmedetomidine 0.5 µg/kg, and Group R (n=30) receiving 20 ml of 0.25% ropivacaine alone. All patients will be educated preoperatively regarding pain assessment using the Numeric Rating Scale and satisfaction using the Likert scale, and will undergo pre-anaesthetic evaluation a day prior to surgery. After standard fasting, patients will be monitored intraoperatively with ASA standard monitors, intravenous access will be secured, and Ringer lactate will be started at 10 ml/kg. Under aseptic precautions and ultrasound guidance, the PENG block will be performed preoperatively by injecting the assigned drug into the musculofascial plane between the psoas tendon and pubic ramus. Subsequently, all patients will receive subarachnoid block at L2–L5 interspace using a 25G Quincke needle with 0.5% hyperbaric bupivacaine at a dose of 0.3 mg/kg. Hemodynamic parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded at baseline and perioperatively, and patients will be monitored and managed for complications such as hypotension, bradycardia, or local anesthetic systemic toxicity.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of age 18 tp 75 years of both gender scheduled for hip surgery lasting upto 3 hours under regional or general anesthesia.
  • American Society of Anesthesiologists physical status 1 to 3
  • Ability to report pain scores using the Numeric Rating Scale.

排除标准

  • Allergy to ropivacaine or dexmedetomidine.
  • Contraindications to regional anesthesia
  • Pre-existing chronic pain conditions.
  • Severe hepatic or renal impairment
  • Cognitive impairment or inability to comply with pain assessments.
  • Refusal to participate.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Prajjal Das

Uttar pradesh University of medical sciences

研究点 (1)

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