Superficial Cervical Plexus BlockNCT03695211
Ultrasound-guided Precise Superficial Cervical Plexus Block
A study testing Conventional landmark technique and Precise block technique in people with Superficial Cervical Plexus Block, run by Xin Jiang, MD at 1 site in China.
Trial summary
This prospective, randomized, observer-blinded study compared ultrasound-guided superficial cervical plexus block positioned by the great auricular nerve or conventional landmark technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Superficial Cervical Plexus Block
- What is being tested?
- Conventional landmark technique and Precise block technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
- Patients undergoing neck and shoulder surgery
Who cannot join
- Communication barriers, unable to objectively describe symptoms
- Nerve block contraindicated
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Hongbin Yuan, M.D, 86-21-81885821, jfjczyy@163.com
About this study
Official title: A Randomized Controlled Clinical Trial of Ultrasound-guided Superficial Cervical Plexus Block Positioned by the Great Auricular Nerve or Conventional Landmark Technique
This prospective, randomized, observer-blinded study compared ultrasound-guided superficial cervical plexus block positioned by the great auricular nerve or conventional landmark technique.
Read the detailed description
Ultrasound guidance has become a reliable adjunct for brachial plexus, femoral, and sciatic nerve blocks. Furthermore, US can also be used to anesthetize purely sensory nerves such as the lateral femoral cutaneous and saphenous nerves. The superficial cervical plexus (SCP), a sensory neural plexus, supplies the skin overlying the ear, neck, angle of the mandible, shoulder, and clavicle. Traditionally, the SCP is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle. Unlike brachial plexus, sciatic nerve, etc., the SCP often cannot be displayed directly under ultrasound. The purpose of ultrasound guidance was to inject the local anesthetic solution into the correct intermuscular plane between the sternocleidomastoid and scalene muscles. In previous studies, the midpoint of the posterior border of the sternocleidomastoid muscle was often selected as the puncture point. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory. Ultrasound guidance does not increase the success rate of SCP block compared with traditional technique.
The conventional landmark ultrasound guidance technique (LM group) selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point, but the anatomical difference of the individual cannot be considered. It may be the reason why ultrasound guidance cannot improve the success rate of the SCP block.
The great auricular nerve is the largest branch of the SCP and can be identified under ultrasound. This study intends to indirectly locate the SCP by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). The method of precise SCP block at GAN Point under ultrasound guidance (GAN Group) was explored and compared with the LM Group.
- Conditions
- Superficial Cervical Plexus Block
- Being tested
- Conventional landmark technique, Precise block technique
- Keywords
- great auricular nerve, sternocleidomastoid muscle, ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional landmark techniqueProcedure or surgery
inject at the midpoint of the posterior border of the sternocleidomastoid muscle
Precise block techniqueProcedure or surgery
inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle
| Study group | Role | What they receive |
|---|---|---|
| LM group | Active comparator | LM group use conventional landmark technique, which selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point of superficial cervical plexus block Receives: Procedure: Conventional landmark technique |
| GAN Group | Experimental | This group firstly locate the superficial cervical plexus by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). GAN Group apply the precise block technique, selects the GAN Point as the puncture point of superficial cervical plexus block Receives: Procedure: Precise block technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of block success rate in each group
Sensory blockade of the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves was graded according to a 3-point scale using a pinprick test: 2 = no block, 1 = analgesia (patient can feel touch, not pain), 0 = anesthesia (patient cannot feel touch). We considered a block to be successful if, at 15 mins, a score of 0 or 1 was achieved for each of the 4 nerves.
Measured: up to 15minutes
Secondary outcomes (2)
Comparison of onset time of success block in each group
onset time means time interval from completion of injection to block score of 0(patient cannot feel touch) or 1(patient can feel touch, not pain)
Measured: up to 15minutes
Comparison of pain score after surgery at PACU in each group
Use NRS score to assess pain level, The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 means no pain, 1-3 means mild pain, 4-6 means moderate pain, 7-10 means severe pain.
Measured: Day of surgery, Arrival time of PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 May 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Cervical Plexus BlockStudies of the same condition, open and under way.
- 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
- Model description
- Randomize, double blind, prospective
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Jiang, MD, Shanghai Changzheng Hospital
- Investigators
- Xin Jiang, M.D, Principal investigator, Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695211
- Sponsor's protocol ID
- CHANGZHENG2018-19
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Ultrasound-guided Superficial Cervical Plexus Block Positioned by the Great Auricular Nerve or Conventional Landmark Technique
- ClinicalTrials.gov ID
- NCT03695211
- Acronym / sponsor ID
- CHANGZHENG2018-19
- Conditions
- Superficial Cervical Plexus Block
- Keywords
- great auricular nerve, sternocleidomastoid muscle, ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xin Jiang, MDUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 4 Oct 2018 (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.
This prospective, randomized, observer-blinded study compared ultrasound-guided superficial cervical plexus block positioned by the great auricular nerve or conventional landmark technique.
Detailed description
Ultrasound guidance has become a reliable adjunct for brachial plexus, femoral, and sciatic nerve blocks. Furthermore, US can also be used to anesthetize purely sensory nerves such as the lateral femoral cutaneous and saphenous nerves. The superficial cervical plexus (SCP), a sensory neural plexus, supplies the skin overlying the ear, neck, angle of the mandible, shoulder, and clavicle. Traditionally, the SCP is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle. Unlike brachial plexus, sciatic nerve, etc., the SCP often cannot be displayed directly under ultrasound. The purpose of ultrasound guidance was to inject the local anesthetic solution into the correct intermuscular plane between the sternocleidomastoid and scalene muscles. In previous studies, the midpoint of the posterior border of the sternocleidomastoid muscle was often selected as the puncture point. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory. Ultrasound guidance does not increase the success rate of SCP block compared with traditional technique.
The conventional landmark ultrasound guidance technique (LM group) selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point, but the anatomical difference of the individual cannot be considered. It may be the reason why ultrasound guidance cannot improve the success rate of the SCP block.
The great auricular nerve is the largest branch of the SCP and can be identified under ultrasound. This study intends to indirectly locate the SCP by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). The method of precise SCP block at GAN Point under ultrasound guidance (GAN Group) was explored and compared with the LM Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomize, double blind, prospective
| Arm | Type | Receives |
|---|---|---|
| LM group | Active comparator | Procedure: Conventional landmark techniqueLM group use conventional landmark technique, which selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point of superficial cervical plexus block |
| GAN Group | Experimental | Procedure: Precise block techniqueThis group firstly locate the superficial cervical plexus by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). GAN Group apply the precise block technique, selects the GAN Point as the puncture point of superficial cervical plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
- Patients undergoing neck and shoulder surgery
Key exclusion criteria (2 listed)
- Communication barriers, unable to objectively describe symptoms
- Nerve block contraindicated
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 |
|---|---|---|
| Conventional landmark techniqueinject at the midpoint of the posterior border of the sternocleidomastoid muscle | Procedure or surgery | LM group |
| Precise block techniqueinject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle | Procedure or surgery | GAN Group |
Primary outcome
Comparison of block success rate in each group
Time frame: up to 15minutes
Sensory blockade of the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves was graded according to a 3-point scale using a pinprick test: 2 = no block, 1 = analgesia (patient can feel touch, not pain), 0 = anesthesia (patient cannot feel touch). We considered a block to be successful if, at 15 mins, a score of 0 or 1 was achieved for each of the 4 nerves.
2 secondary outcomes
Comparison of onset time of success block in each group
Time frame: up to 15minutes
Comparison of pain score after surgery at PACU in each group
Time frame: Day of surgery, Arrival time of PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xin Jiang, M.D principal investigator
Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional landmark technique and Precise block technique in people with Superficial Cervical Plexus Block, run by Xin Jiang, MD at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbin Yuan, M.D (86-21-81885821, jfjczyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of block success rate in each group (time frame: up to 15minutes). 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 2 Jan 2020.