The Safety and Efficacy of Surgical Rectus Sheath Block Compared to Subdermal Infiltration of Local Anaesthetic for Postoperative Analgesia After Elective Cesarean Section: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- postoperative pain during rest
研究概览
简要总结
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath space under direct vision before closure of the anterior abdominal wall. Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25% Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.
详细描述
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath space under direct vision before closure of the anterior abdominal wall. Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25% Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.
All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS). Primary outcome parameters were VAS score during rest and the need for additional analgesics during the first 48 post-operative hours. Other parameters will be time of start of lactation and ambulation, length of post-operative hospital stay, and occurrence of side effects or complications.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with singleton pregnancies.
- •Gestational age 37 to 41 weeks.
- •Surgical history: no history of previous surgeries or history of previous 1 cesarean section,
- •Age: 20 -35 years old,
- •American Society of Anesthesiologists physical status classifications II (healthy pregnancy or with mild systemic disease) [Amr E. Abouleish et. al. 2015],
- •Scheduled for elective cesarean section
- •BMI: 18.5 - 35 kg/m2.
排除标准
- •if they had American Society of Anaesthesiologists (ASA) status III and above (with severe systemic disease),
- •Patients with BMI < 18.5 or > 35 kg/m2 were excluded as they require a different dosage of drug for spinal anesthesia,
- •History of previous 2 Caesarian or more,
- •Known allergy to the drug used (bupivacaine),
- •Contraindication to NSAID: patients with suspected or manifest bleeding disturbances, allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously had shown marked side effects after NSAID, the presence of liver or kidney disease, abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced hypertension or pre-eclampsia
- •Bleeding disorders, e.g.: thrombocytopenia,
- •Neurological disorders associated with sensory alterations, e.g., Transverse myelitis can cause back pain, abnormal sensations in the trunk and genital region and legs such as sensory loss or paresthesias (abnormal sensations such as burning, tickling, pricking, numbness, coldness, or tingling).
- •Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread pain due to arthralgia, myalgia or serositis.
- •Requiring general anesthesia,
- •if vertical abdominal incision was required,
- •Local infection at the site of injection or
- •The inability to provide a pain score, e.g., visual impairement.
结局指标
主要结局
postoperative pain during rest
时间窗: 6 hours
All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)
the amount of additional analgesics consumption post-operatively for pain relief.
时间窗: 48 hours
assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic
次要结局
- time of start of lactation(24 hours)
- time of start of ambulation(24 hours)
- length of post-operative hospital stay(24 hours)
- development of of side effects or complications.(24 hours)
研究者
Ahmed M Maged, MD
Professor of Obstetrics and Gynecology at Cairo University
Cairo University