Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries

Official title

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

Overview

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

Detailed description

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.

Interventions

• Procedure superficial cervical plexus nerve block
  The fascial plane delineating the space between the levator scapulae and SCM can then be detected. Within this striated, hyperechoic substance, a hypoechoic cluster representing the superficial cervical plexus can be visualized, typically located just deep to the posterior surface of the lateral SCM. With an in-plane technique, 22-G needle is introduced parallel to the ultrasound beam, proceeding from the posterolateral to the medial direction. The needle will be advanced through the skin and p
• Drug Saline (0.9% NaCl)
  patient will recive saline
• Drug Bupivacaine
  10 mL of 0.25% bupivacaine will be administered in a supine position with the head turned opposite to the side of the block.

Primary outcome measures

• the first call for rescue analgesia [Time frame: 24 HOURS]

Secondary outcome measures (2)

• The total analgesic requirement [Time frame: 24 hours.]
• Pain scores; Visual Analouge Scale (VAS) score [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

• • 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.

Exclusion criteria

• • Patient refusal

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07236086 · SCPB267

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗