Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-Blind
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 36 weeks
- •Elective cesarean section
- •Transverse segmental caesarean section Pfannenstiel type
- •Spinal anesthesia
- •Maternal age 18 to 45 years
- •Any gravaparity
- •Patient ASA I or II
排除标准
- •Any patient who does not meet the inclusion criteria.
- •Emergency cesarean section
- •History of chronic or neuropathic pain
- •Patient with cardiopulmonary disease
- •Known allergies to the drugs used in the study
- •Patient who does not wish to participate in the study
研究组 & 干预措施
Bupivacaine
20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
干预措施: Bupivacain (Drug)
Placebo
20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
干预措施: Placebo (Drug)
结局指标
主要结局
Post operative pain
时间窗: 72 hours
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)
次要结局
- Need for rescue medication(72 hours)
研究者
Osvaldo A. Reyes T.
Chair of the Research Department
Saint Thomas Hospital, Panama