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

NCT07236086 | Not Yet Recruiting

• 1 other identifier: SCPB267
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Maxillofacial Surgeries

Outcome Measures

Primary Outcomes (1)

• the first call for rescue analgesia

  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

  24 HOURS

Secondary Outcomes (2)

• The total analgesic requirement

  24 hours.

• Pain scores; Visual Analouge Scale (VAS) score

  24 hours

Study Arms (2)

control group

PLACEBO COMPARATOR

patients will recive IV saline only

Drug: Saline (0.9% NaCl)

study group

ACTIVE COMPARATOR

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

Procedure: superficial cervical plexus nerve block; Drug: Bupivacaine

Interventions

superficial cervical plexus nerve block PROCEDURE

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 platysma under real-time ultrasound guidance until it approaches to the plexus. Aspiration will be performed to ensure the needle tip is not within a vascular structure.

Also known as: SCPB

study group

Saline (0.9% NaCl) DRUG

patient will recive saline

control group

Bupivacaine DRUG

10 mL of 0.25% bupivacaine will be administered in a supine position with the head turned opposite to the side of the block.

study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

small cardioactive peptide B; Sodium Chloride; Bupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rahma M. Atef, MBBCH

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahma M. Atef, MBBCH

CONTACT

01061574582; rahmaelkalyouby@gmail.com

Shimaa A. Hassan, M.D.

CONTACT

01002953253; Shimaa.abbas@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11