Effects of Fentanyl Vs Dexmedetomidine as Adjuvants to Bupivacaine in Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Arthroscopic Shoulder Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
This study aimed to evaluate the effect of fentanyl versus dexmedetomidine as adjuvants to bupivacaine with comparison to bupivacaine alone in ultrasound-guided erector spinae plane block on the quality and duration of pain control in patients undergoing arthroscopic shoulder surgeries.
详细描述
Shoulder arthroscopic surgery is one of the most common surgical procedures performed in daily practice, for many surgical indications as rotator cuff tears, stiffness and instability, this procedure has a well - documented postoperative pain.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies, percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty.
Fentanyl as an additive to 0.25% bupivacaine in paravertebral block has been found to reduce the rescue analgesic consumption as well as cumulative pain scores at rest and on movement after breast surgery.
Dexmedetomidine is highly selective than clonidine, specific and potentα2-adrenergic agonist having analgesic, sedative, antihypertensive, and anesthetic sparing effects when used in systemic route.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes.
- •Age from 21 to 60 years.
- •Belonging to American Society of Anesthesiologists (ASA) physical status I and II.
- •Underwent shoulder arthroscopic surgery.
排除标准
- •Patients who were known to have an allergy to amide type local anesthetics, dexmedetomidine, or fentanyl.
- •Patients who were receiving non-steroidal anti-inflammatory drugs or any chronic drugs for pain management in the past four weeks.
- •Had a history of drug dependency or substance addiction.
- •Body mass index (BMI) of 18.5 or higher.
- •Had a severe spinal deformity.
- •Had an uncontrolled concomitant medical condition.
- •Had a local skin infection at the injection site or spinal metastasis.
研究组 & 干预措施
ESPB with Fentanyl group
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + Fentanyl 1µg/kg) at T2.
干预措施: Bupivacaine 0.25% + Fentanyl 1µg/kg (Drug)
ESPB with Dexmedetomidine group
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2.
干预措施: Bupivacaine 0.25% + dexmedetomidine 1µg/kg (Drug)
ESPB with bupivacaine alone
Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
Degree of pain
时间窗: 24 hours postoperatively
Assessment of postoperative pain was done with numerical rate scale \[numerical rate score (NRS); 0=no pain and 10=worst possible pain\]. At post-anesthesia care unit (PACU) then 2, 4, 6, 8, 12, and 24 hours postoperative.
次要结局
- Time of first rescue analgesia(24 hours postoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Total amount of morphine consumption(24 hours postoperatively)
- Length of hospital stay(Till the discharge from hospital (Up to 2 weeks))
研究者
Mohamed Mohsen Kamel Sheta
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University