Comparative Study Between Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block for Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF) Surgery A Double Blinded Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The total nalbuphine consumption in mg
研究概览
简要总结
Anterior cervical discectomy and fusion (ACDF) nowadays is considered a common procedure.postoperative pain can hinder recovery and prolong hospital stay. The superficial cervical plexus block (SCPB) is a safe and simple technique that had been found to allow good pain relief in neck surgeries. The main drawback of SCPB was short duration, so adjuvants as dexmedetomidine and opioids has been used to increase analgesic duration and decrease the use of opioids.
The current study will compare the efficacy of dexmedetomidine and nalbuphine as adjuvants to bupivacaine in SCPB in anterior cervical fusion surgeries.
详细描述
The aim of the current study is to evaluate whether the addition of Dexmedetomidine to bupivacaine is comparable to the addition of nalbuphine in superficial cervical plexus block in patients undergoing ACDF.
thrity patients will be recruited. Patients will be divided randomly into either group A in which patients will receive SCPB consisting of bupivacaine 0.25%, dexmedetomidine 1 μg/kg (precedex 100mcg/ml), and adrenaline 1:200,000 in a total volume of 10ml normal saline, or Group B in which patients will receive SCPB consisting of bupivacaine 0.25% and 10 mg of Nalbuphine (nalufin 20mg/ml) and adrenaline 1:200,000 in a total volume of 10ml normal saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Physical status ASA I and ASA ll.
- •Both males and females
- •Age 21- 60 years.
- •Patients undergoing elective anterior cervical discectomy and fusion for 1 or 2 levels.
排除标准
- •Patient refusal.
- •Patients undergoing anterior cervical vertebrectomy and reconstruction.
- •Patients with a history of allergy to local anesthetics or any used drugs in study.
- •Infection at the site of the block.
- •Patients with multiple cervical spine traumas.
- •Patients having surgery for malignant tumors.
- •Pre-existing peripheral neuropathies.
- •Pregnant female.
- •Patients with uncontrolled hypertension or cardiac problems as (heart block, sick sinus syndrome and ischemic heart disease).
- •Patients with coagulopathy (INR>1.5).
- •Patients with failed block.
研究组 & 干预措施
Dexmedetomidine group
Patients will be subjected to SCPB consisting of bupivacaine 0.25%, dexmedetomidine 1 μg/kg (precedex 100mcg/ml), and adrenaline 1:200,000 in a total volume of 10ml normal saline.
干预措施: Dexmedetomidine in superficial cervical plexus block (Drug)
Nalbuphine group
Patients will be subjected to SCPB consisting of bupivacaine 0.25% and 10 mg of Nalbuphine (nalufin 20mg/ml) and adrenaline 1:200,000 in a total volume of 10ml normal saline.
干预措施: Nalbuphine in superficial cervical plexus block (Drug)
结局指标
主要结局
The total nalbuphine consumption in mg
时间窗: The 1st 48 hours starting after patient transfer to the PACU.
The total nalbuphine consumption measured in mg during the 1st 48 hours postoperatively starting after patient transfer to the PACU.
次要结局
- heart rate (beats/min)(At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.)
- Postoperative visual analogue scale (VAS) pain score(At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .)
- Time to first postoperative rescue analgesia(Postoperative 48 hours)
- Incidence of postoperative complications(Postoperative 48 hours)
- Mean arterial blood pressure (MAP)(Intraoperatively ,at baseline and every half an hour till the end of surgery, then at 2,4,8,12,18,36 and 48 hours postoperatively.)
- Ramsay Sedation Scale(30 min, 1, 2, 4, 6, and 12, 36 and 48 hours postoperatively.)
研究者
Doaa Fawzy Abd El Fattah Hassan
Lecturer of anesthesia,surgical ICU and pain management
Kasr El Aini Hospital