Does Bupivacaine Infiltration Reduce Postoperative Pain in Patients With Cesarean Section?
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- average opioid consumption
研究概览
简要总结
This is a double-blind randomized controlled trial to assess the efficacy of local infiltration of bupivacaine versus placebo, in reducing postoperative pain. The severity of pain will be assessed in terms of mean score on visual analogue scale, opioid requirement and average duration of hospital stay.
详细描述
Objective: To compare the effect of bupivacaine wound infiltration with placebo during caesarean section in terms of mean pain scores, analgesic requirement, and duration of hospital stay
Introduction:
Over the last several decades, the rate of caesarean has increased rapidly.According to the data collected from 150 countries, almost 18.6% of the total births occur by caesareansection, with rates ranging from 6% to 27% in different regions. In Egypt and Turkey, the rate of caesarean section is more than 50%. In Pakistan, caesarean section rate was found to be 15.8% in 2013, with a rate of 11.5% in rural areas and 25.6% in the urban population.
Caesarean section is the most commonly performed surgical procedure nowadays and is associated with moderate to severe pain after the surgery. Pain after caesarean section occurs due to inadvertent damage to parietal peritoneum and nerve supply of skin.According to a survey done in America in 2003, it was found that upto 70% of the patients will experience severe pain postoperatively. Severe pain after caesarean section specifically affects mother-baby bonding, lactation, and patient recovery. It also leads to a prolonged hospital stay, reduced mobility, and consequently increasing the risk of thromboembolic disease in the postoperative period. Severe pain aftercaesarean delivery has also been found to be associated with postnatal depression and pain persisting after 8 weeks of delivery.Incaesarean delivery, the provision of effective postoperative analgesia is of key importance to facilitate early ambulation and infant care. It is also very important that the type of analgesia providedis safe, effective,and has minimal side effects for the mother and her baby.
The most appropriate method of analgesia for postoperative pain after caesarean section remains uncertain.Different methods have been used for this purpose. Parenteral opioids are the most commonly used method but associated nausea, vomiting, sedation, and risk of respiratory depression in mother and baby limits its use. Continuous epidural analgesia or patient-controlled analgesia also provide effective analgesia and have fewer adverse effects butare expensive and require special equipment and expertise.Infiltration of local anesthetic into subcutaneous tissue around the incision site has also been thought to relieve pain after caesarean section. Local anesthetic drugslike lignocaine and bupivacaine inhibit nerve impulses from the site of injury thus providing an analgesic effect. However,in this regard, there is no consistent evidence.Some studies show high efficacy while others report no benefit.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Caesarean section will be done under spinal anesthesia by a well-trained consultant obstetrician. The surgeon will be provided with a 20 ml syringe filled either with 20 ml of 0.5% Bupivacaine or 20 ml of placebo (distill water). The syringe will be prepared by our researcher obstetrician. The contents of the syringe will be determined by numbers generated from the computer and the operating surgeon will be unaware of these contents. Before closing the skin incision, the operating surgeon will infiltrate the solution in subcutaneous tissue around the incision. Severity of pain , need for amount of opioids and duration of hospital stay will be assesed by doctor incharge in postoperative ward.
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with age between 20-40 years, American Society of Anesthesiologist (ASA) class II, BMI < 35 at the time of surgery, a period of gestation 37+0- 40+0 weeks, elective caesarean section done under spinal anesthesia, skin incision pfennensteil and lower segment transverse incision on the uterus.
排除标准
- •allergy to local anesthetic, emergency caesarean section, conversion of spinal anesthesia to general anesthesia, caesarean section due to abnormal placentation, midline skin incision, upper segment incision on uterus
研究组 & 干预措施
Experimental group
20ml of 0.5% bupivacaine is infiltrated in the subcutaneous tissue around the incision site
干预措施: Bupivacain (Drug)
Placebo group
20 ml of distill water is infiltrated in the subcutaneous tissue around the incision site
干预措施: Bupivacain (Drug)
结局指标
主要结局
average opioid consumption
时间窗: within first 24 hours after the surgery
average consumption of tramadol injection
average pain score on Visual analogue scale
时间窗: in first 12 hours after the surgery
average pain score on Visual analogue scale in first 12 hours after the surgery
次要结局
- average duration of hospital stay(3 months)
研究者
arshad khushdil
Dr Arshad Khushdil
Armed Forces Hospital, Pakistan
