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临床试验/CTRI/2025/10/095633
CTRI/2025/10/095633尚未招募4 期

Comparison Of Postoperative Analgesic Efficacy Of 0.5 Percentage Ropivacaine With Dexmedetomidine Versus 0.5 Percentage Ropivacaine With Nalbuphine In Ultrasound Guided Erector Spinae Plane Block For Breast Augmentation Surgeries A Prospective Randomized Double Blinded Study

Mohammed Asjad T1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in minutes or hours within 24 hours post surgery.

研究概览

简要总结

This prospective, randomized, double blind study was conducted to compare the postoperative analgesic efficacy of two drug combinations in ultrasound guided erector spinae plane ESP block for patients undergoing breast augmentation surgery. One group received 0.5 Percentage ropivacaine with dexmedetomidine, while the other received 0.5 Percentage ropivacaine with nalbuphine.

The study assessed parameters such as

Duration and quality of postoperative analgesia

Total rescue analgesic requirement

Hemodynamic stability and side effects

The results indicated which adjuvant dexmedetomidine or nalbuphine when combined with ropivacaine, provided superior and longer-lasting pain relief with minimal adverse effects.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Patients under ASA Physical Status I and II undergoing breast augmentation surgery Plastic Surgery.
  • Gender Transgender patients.
  • Patients with BMI between 20 to 30 kg per m².

排除标准

  • Severe spinal deformity.
  • Known allergy to local anaesthetics.
  • Systemic illnesses such as uncontrolled hypertension, diabetes, seizure disorder, cardiopulmonary disease.
  • Bleeding disorders, block site infection, hepatic or renal dysfunction.
  • BMI more than 30 kg per m².
  • Patients on anticoagulants/blood thinners.
  • History of head injury.
  • Psychiatric illness.

结局指标

主要结局

Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in minutes or hours within 24 hours post surgery.

时间窗: Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in baseline , 12th hr and 24th hr post surgery.

次要结局

未报告次要终点

研究者

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

Mohammed Asjad T

Shri Sathya Sai Medical Collgege And Research Institute.

研究点 (1)

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