Maxillofacial SurgeriesNCT07236086
Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries
A study testing superficial cervical plexus nerve block, Saline (0.9% NaCl) and Bupivacaine in people with Maxillofacial Surgeries, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillofacial Surgeries
- What is being tested?
- superficial cervical plexus nerve block, Saline (0.9% NaCl) and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • Patient refusal
- Coagulopathy
- Local infection ate the site of injection
- Pre-existing neuropathy or neurological disease
- Hypersensitivity to local anaesthetics used
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries : A Comparative Randomized Control Study
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
Read the 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.
- Conditions
- Maxillofacial Surgeries
- Being tested
- superficial cervical plexus nerve block, Saline (0.9% NaCl), Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial cervical plexus nerve blockProcedure or surgery
Also called SCPB
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.
Saline (0.9% NaCl)Drug
patient will recive saline
BupivacaineDrug
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 | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients will recive IV saline only Receives: Drug: Saline (0.9% NaCl) |
| study group | Active comparator | patient will recived superficial Cervical plexus Block with 10 mL of 0.25% bupivacaine Receives: Procedure: superficial cervical plexus nerve block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 HOURS
Secondary outcomes (2)
The total analgesic requirement
The total analgesic requirement of Nalbuphine in mg given postoperatively
Measured: 24 hours.
Pain scores; Visual Analouge Scale (VAS) score
visual analogue scale (VAS) at rest and when coughing postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial SurgeriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Mohamed Atef Mohamed, Assiut University
- Investigators
- Rahma M. Atef, MBBCH, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236086
- Sponsor's protocol ID
- SCPB267
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Maxillofacial Surgeries : A Comparative Randomized Control Study
- ClinicalTrials.gov ID
- NCT07236086
- Acronym / sponsor ID
- SCPB267
- Conditions
- Maxillofacial Surgeries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Saline (0.9% NaCl)patients will recive IV saline only |
| study group | Active comparator | Procedure: superficial cervical plexus nerve block, Drug: Bupivacainepatient will recived superficial Cervical plexus Block with 10 mL of 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age 18-65 years
Key exclusion criteria (5 listed)
- • Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superficial cervical plexus nerve blockAlso: SCPBThe 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. | Procedure or surgery | study group |
| Saline (0.9% NaCl)patient will recive saline | Drug | control group |
| Bupivacaine10 mL of 0.25% bupivacaine will be administered in a supine position with the head turned opposite to the side of the block. | Drug | study group |
Primary outcome
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
2 secondary outcomes
The total analgesic requirement
Time frame: 24 hours.
Pain scores; Visual Analouge Scale (VAS) score
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahma M. Atef, MBBCH principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing superficial cervical plexus nerve block, Saline (0.9% NaCl) and Bupivacaine in people with Maxillofacial Surgeries, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahma M. Atef, MBBCH (01061574582 ext. 002, rahmaelkalyouby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first call for rescue analgesia (time frame: 24 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.