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临床试验/NCT07236086
NCT07236086尚未招募不适用

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries : A Comparative Randomized Control Study

Assiut University0 个研究点目标入组 70 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
the first call for rescue analgesia

研究概览

简要总结

The superficial cervical plexus (SCP) originates from the anterior rami of C1-C4 and gives four cutaneous branches supplying the anterolateral neck, external ear, and shoulder tip (1). A superficial cervical plexus block (SCPB) is performed by subcutaneous injection at the midpoint of the posterior border of the sternocleidomastoid, targeting these sensory branches using either landmarks or ultrasound guidance. The goal of the ultrasound (US)-guided technique of superficial cervical plexus nerve block is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 (2). SCPB has been successfully used for analgesia in mandibular, tympanomastoid, thyroid, submandibular, and clavicular surgeries, and can even serve as the sole anaesthetic technique in external ear procedures (3, 4). As complications may arise while administrating a SCPB, an adequate understanding of the block physiology and local anesthetic toxicity can mitigate these issues. Superficial cervical plexus block shares common complications with other local anesthetic-based nerve blocks including intravascular injection into a vein or an artery, hematoma formation, infection risk and local anesthetic toxicity. It is worthy to refer that complications are of a higher incidence in deep blocks than superficial ones

详细描述

The superficial cervical plexus (SCP) originates from the anterior rami of C1-C4 and gives four cutaneous branches supplying the anterolateral neck, external ear, and shoulder tip (1). A superficial cervical plexus block (SCPB) is performed by subcutaneous injection at the midpoint of the posterior border of the sternocleidomastoid, targeting these sensory branches using either landmarks or ultrasound guidance. The goal of the ultrasound (US)-guided technique of superficial cervical plexus nerve block is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 (2). SCPB has been successfully used for analgesia in mandibular, tympanomastoid, thyroid, submandibular, and clavicular surgeries, and can even serve as the sole anaesthetic technique in external ear procedures (3, 4). As complications may arise while administrating a SCPB, an adequate understanding of the block physiology and local anesthetic toxicity can mitigate these issues. Superficial cervical plexus block shares common complications with other local anesthetic-based nerve blocks including intravascular injection into a vein or an artery, hematoma formation, infection risk and local anesthetic toxicity. It is worthy to refer that complications are of a higher incidence in deep blocks than superficial ones .

Based on this background, the present study aims to evaluate the analgesic effect of US-guided SCPB in maxillofacial surgeries compared with conventional general anaesthesia, focusing on intra- and postoperative systemic analgesic requirements, pain scores on the visual analog scale (VAS), total duration of analgesia, vital parameters, and the incidence of postoperative complications.

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
Double (Participant, Outcomes Assessor)

盲法说明

The patient, surgeon, the outcome assessor and the statistician will be blinded about patient's group allocation. The anesthetist responsible for the patient intraoperatively will not be blinded to patient group allocation.

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

入选标准

  • • Age 18-65 years
  • BMI < 30 kg/m2
  • American Society of Anesthesiologists physical status classification (ASA) I - III
  • Patients scheduled for maxillofacial procedures involving submandibular area e.g. submandibular and submental abscesses, neck region e.g. cervical lymph node biopsies and ear lobe procedures.

排除标准

  • • Patient refusal
  • Coagulopathy
  • Local infection ate the site of injection
  • Pre-existing neuropathy or neurological disease
  • Hypersensitivity to local anaesthetics used

研究组 & 干预措施

control group

Placebo Comparator

patients will recive IV saline only

干预措施: Saline (0.9% NaCl) (Drug)

study group

Active Comparator

patient will recived superficial Cervical plexus Block with 10 mL of 0.25% bupivacaine

干预措施: superficial cervical plexus nerve block (Procedure)

study group

Active Comparator

patient will recived superficial Cervical plexus Block with 10 mL of 0.25% bupivacaine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

the first call for rescue analgesia

时间窗: 24 HOURS

the elapsed time from the time of block until the first postoperative analgesic use after the end of the surgery, which will be administrated based on patient request

次要结局

  • The total analgesic requirement(24 hours.)
  • Pain scores; Visual Analouge Scale (VAS) score(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rahma Mohamed Atef Mohamed

Principle Investigator

Assiut University

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