Comparison of the Analgesic Efficacy of Three Different Concentrations of Bupivacaine in Ultrasound Guided Erector Spinae Plane Block in Hip Surgeries: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The total 24 hours amount of morphine consumption
研究概览
简要总结
The prevalence of hip replacement surgery is increasing nowadays. Patients are usually older age and suffer from comorbidities may be an anesthetic and analgesic challenge. Erector spinae plane block (ESPB) is a newly described technique that is has been demonstrated in previous studies for chronic and acute pain treatment. The exact volume and concentration of local anesthetic (LA) to be used in ESPB is not well established.
详细描述
Aim of the work is to compare the analgesic effects of three different concentrations of the same volume of local anesthetics; 30 ml of 0.50% vs 0.375% vs 0.25% bupivacaine in patients undergoing hip surgeries.
Prospective randomized double blinded study that will be conducted in at Kasr El-Ainy hospital orthopedic surgical theater.
patients, undergoing hip surgeries will be randomly allocated into three equal groups, each (n=44), using computerized generated random tables
- Group F: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.50% bupivacaine.
- Group M: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.375% bupivacaine.
- Group H: 44 patients will receive single shot of erector spinae block at the level of L4with 30ml 0.25% bupivacaine .
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders (Males and females).
- •Type of surgery; unilateral elective hip surgeries
- •Physical status ASA I, II.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- •History of psychological disorders and/or chronic pain.
- •Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- •Infection of the skin at the site of needle puncture area.
- •Patient refusal.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Pregnancy.
- •Patient with surgery duration more than two hours.
研究组 & 干预措施
A (0.5%) group
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
干预措施: Erector spinae plane block Technique (Procedure)
A (0.5%) group
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
干预措施: General anesthesia (Procedure)
A (0.5%) group
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
干预措施: Bupivacaine 0.5% (Drug)
B (0.375%) group
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
干预措施: Erector spinae plane block Technique (Procedure)
B (0.375%) group
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
干预措施: General anesthesia (Procedure)
B (0.375%) group
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
干预措施: Bupivacaine 0.375% (Drug)
C (0.25%) group
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
干预措施: Erector spinae plane block Technique (Procedure)
C (0.25%) group
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
干预措施: General anesthesia (Procedure)
C (0.25%) group
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
The total 24 hours amount of morphine consumption
时间窗: 24 hours postoperative
The total amount of morphine consumption in the first 24 hours postoperatively
次要结局
- Total amount of intraoperative fentanyl(2 hours intraoperatively)
- Numeric Pain Rating Scale(24 hours postoperative)
- Time for first rescue analgesia(24 hours)
- Block related complications(24 hours postoperative)
研究者
Bassant M. Abdelhamid
associate professor
Cairo University