Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Maternal Satisfaction
研究概览
简要总结
Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.
Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.
EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.
We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.
详细描述
OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.
Hypothesis
Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All adult women undergoing elective LSCS under spinal anesthesia
排除标准
- •BMI of more than 35 kg/m2
- •Contraindication to spinal anesthesia
- •Spinal deformity
- •Refusal of regional anesthesia
- •Patients with a history of back surgery
- •confirmed allergy to local anesthetics
- •More than three attempts of needle insertion for inducing spinal anesthesia
研究组 & 干预措施
2% Lidocaine group
In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited) skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal anesthesia induction.
干预措施: 2% lidocaine (Drug)
EMLA cream group
In EMLA (Eutectic Mixture of Local Anesthesia- lidocaine 2.5% and prilocaine 2.5%) cream group, EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion
干预措施: EMLA cream (Drug)
结局指标
主要结局
Maternal Satisfaction
时间窗: After 10 minutes (right after spinal anesthesia procedure is complete)
Maternal Satisfaction Score (end of spinal anesthesia): Very Satisfied Satisfied No comments Unsatisfied Very Unsatisfied
Pain Score (Subjective)
时间窗: After 10 minutes (right after spinal anesthesia procedure is complete)
Visual Analogue Scale pain Score in cm
Pain Score (Objective)
时间窗: During spinal anesthesia procedure
Objective scoring: 1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away
次要结局
未报告次要终点
研究者
Dr. Malika Hameed
Fellow Obstetric Anesthesiology
Aga Khan University