- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236086
Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries
Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries : A Comparative Randomized Control Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rahma M. Atef, MBBCH
- Phone Number: 002 01061574582
- Email: rahmaelkalyouby@gmail.com
Study Contact Backup
- Name: Shimaa A. Hassan, M.D.
- Phone Number: 002 01002953253
- Email: Shimaa.abbas@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
patients will recive IV saline only
|
patient will recive saline
|
|
Active Comparator: study group
patient will recived superficial Cervical plexus Block with 10 mL of 0.25% bupivacaine
|
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.
Other Names:
10 mL of 0.25% bupivacaine will be administered in a supine position with the head turned opposite to the side of the block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the first call for rescue analgesia
Time Frame: 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
|
24 HOURS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The total analgesic requirement
Time Frame: 24 hours.
|
The total analgesic requirement of Nalbuphine in mg given postoperatively
|
24 hours.
|
|
Pain scores; Visual Analouge Scale (VAS) score
Time Frame: 24 hours
|
visual analogue scale (VAS) at rest and when coughing postoperatively
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rahma M. Atef, MBBCH, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCPB267
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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