Evaluation of the Efficacy of Adding Magnesium Sulfate as an Adjuvant to Bupivacaine in Bilateral Ultrasound Guided Paravertebral Block for Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change of postoperative pain intensity
研究概览
简要总结
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures for the treatment of symptomatic cholelithiasis Laparoscopic cholecystectomy has clear benefits when compared with open surgery, but post-operative pain is still a common complaint after it The patient undergoing laparoscopic cholecystectomy suffers from severe post-operative pain, it can prolong hospital stay and lead to increased morbidity Post-operative laparoscopic cholecystectomy pain can be relieved by some methods pre-emptive analgesic regimens containing ketamine, regional anesthesia techniques including paravertebral block Paravertebral Block is a regional anesthetic and analgesic technique which may offer comparable analgesic effectiveness with minimal side effects Paravertebral Block has been used a lot in the last two decades, several studies show its efficacy in, thoracoscopic surgery and laparoscopic cholecystectomy .Paravertebral block is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina, resulting in ipsilateral somatic and sympathetic nerve blockade in multiple dermatomes above and below the site of injection .
Bupivacaine is a local anesthetic that is capable of producing prolonged high quality analgesia in the postoperative period It is shown that paravertebral block using bupivacaine significantly reduces pain score Many drugs have been used as adjuvants to local anesthetic in peripheral nerve block in order to augment its analgesic effect and prolong the duration of the block such as opioids and magnesium sulfate Many studies have reported safety and efficacy of adding magnesium to local anesthetics in various regional anesthetic procedures, such as intrathecal, epidural, caudal, brachial plexus blocks and intravenous regional anesthesia. Magnesium play a major role in central nociceptive transmission, modulation and sensitization of acute and chronic pain states due to its antagonistic effect on N-methyl D-aspartate (NMDA) receptors .
详细描述
Patients and Methods
Patients:
This is a blind prospective randomized controlled study that will be conducted for one year in Mansoura university hospitals after approval from the Institutional Research Board (IRB), Faculty of Medicine, Mansoura University, patients will be interviewed and written informed consents will be obtained. This study will include 26 patients of American Society of Anesthesiologists physical status grade I and grade II, of both sexes, aged between 20-60 years who will be scheduled for laparoscopic cholecystectomy.
Sample size calculation A Priori G-power analysis was done to estimate study sample size. A power of 90% was estimated with type I error of 0.05 to get an analgesic duration difference between groups of approximately 30% to yield of total sample size of 50 cases (25cases per group).
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The groups allocated are concealed in sealed opaque envelopes which were not opened until patient consent was obtained.
The two groups were:
- Control group: Bupivacaine Group (B group) N=25 :
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side. 2. Magnesium Group (M group) N=25 :
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side.
All patients were performed by the same anesthetic team with standard procedure.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective laparoscopic cholecystectomy were enrolled in this study
排除标准
- •patient refusal to participate,
- •Sever renal or cardiac illness,
- •Pulmonary diseases as emphysema or chronic obstructive pulmonary disease
- •Neuromuscular diseases (as myopathies and myasthenia gravies), -Hematological diseases, bleeding or coagulation abnormality,
- •Psychiatric diseases,
- •Local skin infection and sepsis at site of the block,
- •Known hypersensitivity to the study drugs, and Severe chest wall deformity, e.g. scoliosis.
研究组 & 干预措施
Control group: Bupivacaine Group (B group)
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side
干预措施: Bupivacain (Drug)
Control group: Bupivacaine Group (B group)
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side
干预措施: saline (Other)
Magnesium Group (M group)
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side.
干预措施: Bupivacain (Drug)
Magnesium Group (M group)
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side.
干预措施: magnesium sulfate (Drug)
Magnesium Group (M group)
Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side.
干预措施: saline (Other)
结局指标
主要结局
change of postoperative pain intensity
时间窗: first 24 hours postoperatively
measured by visual analogue scale . All patients were familiar with the use of 0 -10 visual analogue scale identifying 0 as no pain and 10 as worst imaginable pain. Pain intensity was assessed at rest and during cough with VAS score at 1, 2, 6, 12 and 24 hours postoperatively. When the patients experienced pain (VAS score \> 3), A bolus dose of IV morphine 0.02 mg/kg was administered till visual analogue scale score ≤ 4 was attained.
次要结局
- change opioid consumption in first 24 hours(first 24 hours postoperatively)
- change of analgesia duration(first 24 hours postoperatively)
研究者
Marwa Ibrahim Mohamed Abdo,MD
Lecturer of Anesthesia and Surgical Intensive Care-Faculty of Medicine - Mansoura University
Mansoura University