A Comparative Study of ultrasound guided Thoracic Paravertebral Block versus ultrasound guided Erector Spinae Plane Block for post operative analgesia in Modified Radical Mastectomy
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total post operative fentanyl consumption in first 24 hours, pain assessment using VAS at 2, 4, 6, 8, 10, 12, 16, 20 & 24 hours post operatively, time for first dose rescue analgesia.
研究概览
简要总结
The aim of the study is to compare the postoperative analgesic efficacy of levobupivacaine in ultrasound guided thoracic paravertebral block vs levobupivacaine in ultrasound guided erector spinae plane block in patients undergoing modified radical mastectomy. The study will be conducted in a comparative manner in GGS Medical College and Hospital, Faridkot on 80 adult females belonging to American Society of Anesthesiologists (ASA) Grade I and II scheduled for modified radical mastectomy under general anaesthesia. Patients will be randomly allocated into two groups of 40 each.
Group P: Patients will receive 20ml of 0.25% Levobupivacaine through USG guided thoracic paravertebral block at T5 level.
Group E: Patients will receive 20ml of 0.25% Levobupivacaine through USG guided erector spinae plane block at T5 level.
The patients will be observed postoperatively for duration till first rescue analgesic requirement, total rescue analgesic consumption, pain score using visual analogue score and any side effects in the form of pneumothorax, hypotension, bradycardia, epidural or intrathecal spread, vascular puncture, nerve damage, horner’s syndrome, infection at injection site, post operative nausea & vomiting, headache or sedation.
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 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients belonging to ASA grade I & II
- •Females aged 18 – 65 years
- •Patient posted for elective unilateral modified radical mastectomy.
排除标准
- •Patients undergoing bilateral MRM.
- •Local infection at the site of block
- •Patients with renal (or) hepatic insufficiency.
- •Known allergy to study drugs
- •Pregnant patients
- •Patients with history of underlying psychological disorder
- •Patient refusal.
结局指标
主要结局
Total post operative fentanyl consumption in first 24 hours, pain assessment using VAS at 2, 4, 6, 8, 10, 12, 16, 20 & 24 hours post operatively, time for first dose rescue analgesia.
时间窗: 24 hours
次要结局
- Secondary outcome measures include intra operative hemodynamic variables and(side effects of respective block)
研究者
Dr Mukesh Kumar
Guru Gobind Singh Medical College and Hospital, Faridkot