Efficacy of Serratus Anterior Plane Block Using Bupivacaine Alone, Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine for Thoracotomy: A Randomized, Double-Blinded Comparative Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The time of 1st rescue analgesia post operative
研究概览
简要总结
We aim to compare efficacy and efficiency of serratus anterior block with bupivacaine alone to bupivacaine/magnesium and bupivacaine /nalbuphine in postoperative analgesia for thoracotomy surgery.
Objectives:
To compare bupivacaine alone, bupivacaine/magnesium and bupivacaine /nalbuphine in serratus anterior plane block for intraoperative and postoperative analgesia for thoracotomy surgery.
- The time for 1st rescue analgesia.
- Calculation of the opioid requirements; (the total intra-operative post-operative morphine consumption in first 24h postoperative).
- Assessment of pain score (VAS)- rest, VAS-movement, VAS-cough during post-operative 24hrs period.
Hypothesis:
We hypothesize that magnesium sulfate and nalbuphine can reduce acute postoperative pain and result in efficacious postoperative analgesia due to block of the lateral cutaneous branches of the intercostal nerves (T2 - T6) by diffusion across the inter-fascial planes.
详细描述
I. Study design prospective, randomized controlled study. II. Study setting and location It will be conducted at El Kasr Al-Aini hospitals, cardiothoracic Surgery, Cairo University.after registration in clinicaltrials.gov and getting a unique number III. Study population patients of both genders, aged (16 - 65) years old, ASA I, II or III scheduled for elective general thoracotomy surgeries will be included. Consenting patients will be randomly allocated to one of three groups: Group B: patients will receive intraoperative serratus block with bupivacaine. Group BMG: patients will receive intraoperative serratus block with bupivacaine/ magnesium.
Group BN: patients will receive intraoperative serratus block with bupivacaine /nalbuphine.
V. Study Procedures
- Randomization:
The patients will be randomized using a computer-generated list of random numbers which will be sealed in closed envelopes. Patients will be randomly allocated to one of the three groups. The study drugs are going to be prepared by anesthetist (who were blinded to the study and did not share in the technique) in labelled syringes, patients into 3 groups by a sealed opaque envelope, and received the study drug as follows: group B (n = 26): (bupivacaine): received bupivacaine 30 mL 0.25%, group BMG (n =26): received bupivacaine 30 mL 0.25% and 500 mg magnesium sulphate. Group BN (n =26): (bupivacaine/nalbuphine): received bupivacaine 30 mL 0.25 % and nalbuphine 0.2 mg/kg. 2. Study Protocol All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications.
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, Investigator)
盲法说明
patient doesn't know which type of drugs given to him in the block , and the investigator who collect postoperative data also doesn't know which type of drugs used in the block
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective thoracotomy or unplanned thoracotomy after failed thoracoscopic surgery
- •Patient with American Society of Anesthesiology ASA I, II or III.
排除标准
- •Patient refusal
- •Contraindication for regional anesthesia
- •Allergy from local anesthetics
- •Bleeding diathesis (Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 50,000/µL.
- •Use of anticoagulants, infection at the puncture site.
- •Presence of severe Chronic renal impairment or acute renal failure, decompensated liver disease, cardiac or psychiatric disorders, GIT ulcers, communication barriers, hearing deficit or high grades of visual deficit that interfere with consenting, VAS assessments, and delirium, or another cognitive dysfunction.
- •Patient intubated preoperatively.
- •Patient will not be extubated immediately postoperatively
- •Opioid tolerant patients.
- •Any contraindications of Magnesium infusion as hypovolemia or severe impaired ventricular systolic function.
- •Contraindication of acetaminophen and Diclofenac sodium administration.
研究组 & 干预措施
Group B
bupivacaine
干预措施: patients will receive intraoperative serratus block with bupivacaine (Drug)
Group BMG
bupivacaine/ magnesium.
干预措施: serratus block with bupivacaine /magnesium (Drug)
Group BN
bupivacaine /nalbuphine.
干预措施: serratus block with bupivacaine with nalbuphine (Drug)
结局指标
主要结局
The time of 1st rescue analgesia post operative
时间窗: one year
if VAS or VAS-movement \>3.
次要结局
- Total amount of morphine (mg) used in 24h post operatively(one year)
- Pain assessment score; (VAS score) VAS-movement and VAS-cough(one year)
- Hemodynamic changes (SBP, DB, MAP)(one year)
- Incidence of local anesthetic toxicity.(one year)
研究者
Ahmed Hussein Sayed Hasan
lecturer of anesthesia , surgical ICU and pin managment
Cairo University