Efficacy of Magnesium Sulfate Added to Bupivacaine in Suprascapular Nerve Block on Duration of Analgesia Following Shoulder Arthroscopy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
- Arthroscopic shoulder surgeries in adults are accompanied with severe immediate postoperative pain reported in approximately 45% of patients. For quicker recovery and rehabilitation of these patients, postoperative analgesia is mandatory.
- Different analgesic modalities have been proposed including parenteral opioids, intra-articular injection of local anesthetics, interscalene brachial plexus block (ISB), and a suprascapular nerve block (SSNB), with varying degrees of effectiveness and multiple reported side effects.
- A recent meta-analysis demonstrates that suprascapular block results in 24-h morphine consumption and pain scores similar to ISB, so, it may be considered an effective and safe alternative for interscalene block in shoulder surgery, with less motor restriction, and fewer complications.
- Different agents are used as adjuvants to local anesthetics during peripheral nerve block to prolong its analgesic action including magnesium sulfate.
- A meta-analysis by Mengzhu et al., concluded that magnesium sulfate combined with local anesthetics in perineural nerve blocks provided better analgesic efficacy and may be a promising analgesic for perineural nerve blocks.
- Antinociceptive effects of magnesium are due to the regulation of calcium influx into the cell and a non-competitive antagonism of the NMDA receptors
详细描述
The aim of this study is to evaluate the effects of magnesium sulfate as an adjuvant to bupivacaine in suprascapular nerve block on the duration and quality of postoperative analgesia following shoulder arthroscopy, postoperative pain VAS scores, intraoperative fentanyl requirements, sedation scores, respiratory depression, postoperative 24 hours cumulative morphine consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind study
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
- •ASA physical status I-III
排除标准
- •Patient's refusal
- •Significant cardiac diseases
- •Significant hepatic diseases
- •Significant renal diseases (serum creatinine ˃ 1.5 mg/dl)
- •Cardiac conduction abnormalities
- •Drug abuse
- •Pregnancy
- •Allergy to study medications
- •Mental disease
- •Communication barrier
- •Coagulopathy
- •Local skin infection
- •Traumatic nerve injury of upper limb
- •Patients receiving opioid analgesics
- •Patients receiving magnesium sulfate
- •Patients receiving beta blockers
- •Patients receiving calcium channel blockers
- •Previous shoulder surgery
研究组 & 干预措施
Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
干预措施: Bupivacaine (Drug)
Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
干预措施: Propofol (Drug)
Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
干预措施: Ultrasound (Device)
Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
干预措施: Sevoflurane (Drug)
Bupivacaine
Ultrasound-guided suprascapular nerve block using bupivacaine will be performed before induction of general anesthesia
干预措施: Rocuronium (Drug)
Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
干预措施: Bupivacaine-magnesium (Drug)
Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
干预措施: Propofol (Drug)
Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
干预措施: Ultrasound (Device)
Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
干预措施: Sevoflurane (Drug)
Bupivacaine-magnesium
Ultrasound-guided suprascapular nerve block using bupivacaine in conjunction of magnesium sulfate will be performed before induction of general anesthesia
干预措施: Rocuronium (Drug)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: For 8 hours after suprascapular nerve block
time from administering the study solution in the suprascapular block till the time for the first rescue morphine request
次要结局
- Intraoperative fentanyl requirements(For 5 hours after suprascapular nerve block)
- Systolic arterial blood pressure(At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively)
- Number of vomiting episodes(For 24 hours after surgery)
- Postoperative cumulative morphine consumption(For 24 hours after surgery)
- Pain score at rest(time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively)
- Pain score on shoulder abduction(time 0 (after extubating) and at 30 minutes, 1 hour , 2 hours, 4hours, 6hours, 8hours,12 hours , 16hours, 20 hours and 24 hours postoperatively)
- Diastolic arterial blood pressure(At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery , every 6 hours up to 24 hours postoperatively)
- Heart rate(At baseline, immediately after induction of anaesthesia, at skin incision, every 15 minutes till the end of surgery, on arrival to PACU, then at 30, 60 minutes after surgery ,every 6 hours up to 24 hours postoperatively)
- The degree of nausea and vomiting(For 24 hours after surgery)
- Number of antiemetics received(For 24 hours after surgery)
- Sedation scores(at 1 hour, 2 hours, and 6 hours postoperatively)