The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of superficial cervical block application on postoperative opioid use in patients undergoing cervical discectomy surgery via anterior approach.
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of superficial cervical block on postoperative opioid consumption in patients undergoing anterior cervical discectomy surgery. Postoperative pain significantly impacts recovery and patient comfort in this type of surgery, where symptoms such as swallowing difficulties, occipito-cervical pain, and positional discomfort are common. While opioids are effective for pain control, their side effects, such as nausea, vomiting, and respiratory depression, may lead to complications, especially in cervical surgeries with potential airway risks.
Superficial cervical block is a simple and safe regional anesthesia technique proven effective in managing pain after thyroid and carotid surgeries. However, its potential benefits in anterior cervical discectomy surgeries have not been extensively studied.
Our hypothesis is that superficial cervical block can reduce postoperative opioid use and provide effective pain management for these patients. Additionally, investigators aim to compare opioid-related side effects and postoperative pain scores between groups with and without the block.
详细描述
This prospective, randomized, double-blind, controlled trial is conducted at Medipol Mega University Hospital in patients undergoing microscopic anterior cervical discectomy and fusion (ACDF). The primary objective is to assess the effect of a superficial cervical plexus block on the incidence of requiring postoperative rescue analgesia. Secondary objectives are total cumulative tramadol consumption, the incidence of opioid-related adverse events (nausea, vomiting, pruritus) and postoperative Numerical Rating Scale (NRS) pain scores at rest and on movement.
Patient selection:
Eligible participants are aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status of I-II, scheduled for unilateral single- or two-level microscopic ACDF under general anaesthesia. Exclusion criteria are bleeding diathesis, anticoagulant therapy, known local anaesthetic or opioid allergy, a history of chronic pain, infection of the skin at the puncture site, and refusal to participate.
Study groups:
Participants are randomly assigned to two groups. Group 1 (control) receives no regional block. Group 2 (intervention) receives a right-sided superficial cervical plexus block at the end of surgery, before awakening.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for unilateral single- or two-level microscopic anterior cervical discectomy and fusion (ACDF) under general anaesthesia
排除标准
- •History of bleeding diathesis,
- •Receiving anticoagulant treatment,
- •Known local anesthetics and opioid allergy,
- •History of chronic pain
- •Infection of the skin at the site of the needle puncture,
- •Patients who do not accept the procedure
研究组 & 干预措施
superficial cervical block
In addition to the routine analgesia given to the control group, a right-sided superficial cervical plexus block is performed at the end of surgery, immediately before awakening, with the patient in the supine position. A high-frequency linear ultrasound probe is placed transversely on the right side of the neck at the level of the fourth cervical vertebra to identify the sternocleidomastoid (SCM) muscle, the investing layer of the deep cervical fascia, the internal jugular vein and the carotid artery. A 50-mm block needle is advanced in plane at a shallow angle, from lateral to medial, towards the posterior border of the SCM. The needle tip is positioned superficial to the investing layer of the deep cervical fascia; neither the SCM nor the prevertebral fascia is traversed. After confirming correct placement with 1-2 mL of saline, 20 mL of 0.25% bupivacaine is injected in this plane.
干预措施: superficial cervical plexus block (Drug)
control group
1 g intravenous paracetamol, 100 mg intravenous tramadol and 4 mg intravenous ondansetron are administered 30 minutes before surgery. Postoperatively, 1 g intravenous paracetamol is given every 8 hours. Rescue analgesia is 1 mg/kg intravenous tramadol when the Numerical Rating Scale score is 4 or above.
结局指标
主要结局
Evaluation of the effect of superficial cervical block application on postoperative opioid use in patients undergoing cervical discectomy surgery via anterior approach.
时间窗: first 24 hours after the operation
The amount of tramadol used as rescue analgesic will be compared between the groups.
Incidence of Requiring Postoperative Rescue Analgesia
时间窗: first 24 hours after the operation
The number of participants requiring tramadol as a rescue analgesic during the first 24 hours after surgery.
次要结局
- The aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.(first 24 hours after the operation)
- Total Cumulative Tramadol Consumption(first 24 hours after the operation)
研究者
Burak Omur
Assistant Professor
Medipol University