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临床试验/CTRI/2026/02/103892
CTRI/2026/02/103892尚未招募不适用

Comparison of Erector Spinae Plane block and Intravenous Dexmedetomidine for postoperative pain relief in patients undergoing breast surgery

Dr Simran Shetty1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1

研究概览

简要总结

This dissertation protocol proposes a prospective, comparative observational study to evaluate and compare the effectiveness of the Erector Spinae Plane (ESP) block versus intravenous dexmedetomidine for postoperative analgesia in patients undergoing mastectomy. Given the high incidence of moderate-to-severe acute pain and the risk of chronic post-mastectomy pain syndrome, the study addresses a clear knowledge gap, as both techniques are well studied individually but lack direct head-to-head comparison.

The study will be conducted at Kasturba Medical College hospitals and will include ASA I–II female patients aged 18–75 years undergoing elective mastectomy under general anesthesia. A total of 74 patients (37 per group) will be enrolled using convenience sampling. Patients will be allocated to either Group A (ultrasound-guided ESP block at T4 with local anesthetic) or Group B (IV dexmedetomidine loading dose followed by infusion). Standardized general anesthesia will be administered to all patients, and postoperative pain will be assessed using VAS scores at 1, 12, and 24 hours.

The primary outcome is postoperative analgesic efficacy, assessed by duration and intensity of pain relief. Secondary outcomes include the requirement for rescue analgesia and comparison of hemodynamic parameters (heart rate, blood pressure, oxygen saturation, respiratory rate), along with monitoring for adverse effects such as hypotension or bradycardia. Data will be analyzed using appropriate parametric or non-parametric tests, with statistical significance set at p < 0.05.

Overall, the study aims to determine which modality provides longer-lasting analgesia, reduced need for rescue analgesics, and better hemodynamic stability, thereby guiding optimal postoperative pain management strategies for mastectomy patients.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • INCLUSION CRITERIA: 1)Female patients aged between 18-75 years 2)Elective mastectomy surgery under general anaesthesia. 3)American society of anaesthesiologists class I.
  • II patients.

排除标准

  • EXCLUSION CRITERIA: 1)Patient refusal.
  • Pregnant patients.
  • Patients with psychiatric diagnosis/cognitive dysfunction 4)Surgical duration more than 6 hrs.

研究者

发起方
Dr Simran Shetty
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Simran Shetty

Kasturba Medical College , Mangalore

研究点 (1)

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