Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The amount of intraoperative fentanyl requirement (mg)
研究概览
简要总结
The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications.
The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.
详细描述
This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.
Study design:
Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes:
Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.
Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 up to 65 years
- •Male gender only
- •ASA physical status I and II
- •Weight 75-100 kg
- •Duration of surgery ≤ 2 hours
- •Scheduled for elective idiopathic gynecomastia surgery
排除标准
- •Patient refusal.
- •Uncooperative patients.
- •Known hypersensitivity to local anesthetic (LA) (bupivacaine).
- •Local infection at the site of injection (TPVB or TIPB).
- •Coagulopathy.
- •History of opioid abuse or chronic analgesic use.
研究组 & 干预措施
Group C
30 patients will receive bilateral tumescent local anesthesia as a control group
干预措施: Tumescent local anesthesia (Drug)
Group TPVB
30 patients will receive bilateral US guided thoracic paravertebral block.
干预措施: Thoracic paravertebral block (Drug)
Group TIPB
30 patients will receive bilateral US guided thoracic interfascial plane block
干预措施: Thoracic interfascial plane block (Drug)
结局指标
主要结局
The amount of intraoperative fentanyl requirement (mg)
时间窗: 3 hours
If the patient complains from pain, fentanyl 25μg intravenously will be administrated.
次要结局
- Degree of patient's satisfaction(6 hours)
研究者
Taysser Mahmoud Abdalraheem
Principal Investigator - Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University