Pain, NeckNCT06244667
Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade
A study testing facet median block with prilocain and facet median block with lidocaine in people with Pain, Neck, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is a common disease in society. In studies, the annual and lifetime prevalence was found to be 37.2% and 48.5%, respectively (1). Neck pain may be axial or radicular. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Pain, Neck
- What is being tested?
- facet median block with prilocain and facet median block with lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Jan 2024
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-79
- A history of axial cervical pain without radicular symptoms for at least 3 months
- NRS score of 4 and above
- Not having had a cervical interventional procedure in the last year
- Patients who cannot achieve adequate pain palliation with pharmacological and physical treatment modalities
Who cannot join
- Patients experiencing cervical radicular pain due to disc herniation or foraminal stenosis and neck pain due to cervical canal stenosis
- Patients with previous cervical surgery
- Patients with psychiatric illnesses that are unstable/uncontrolled with medical treatment
- Pregnant patients
- Bleeding diathesis
- Patients who received epidural steroid injection within the last year
- Patients with known allergies to the substances administered during the procedure (local anesthetic, steroid, contrast material)
- Patients with cervical spondylosis, radiculopathy, myelopathy, spondylolisthesis, compression fracture, previous discitis, sequestered disc, overt disc herniation
Trial locations and contacts
1 site in 1 country.
About this study
Neck pain is a common disease in society. In studies, the annual and lifetime prevalence was found to be 37.2% and 48.5%, respectively (1). Neck pain may be axial or radicular. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. (2) Cervical facet degeneration is a common cause of axial neck pain (3). Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. (2) Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved
Read the detailed description
Neck pain is a common disease in society. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. Cervical facet degeneration is a common cause of axial neck pain. Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved.
Conservative treatment methods for facet joint pain are medical treatment and various physical therapy modalities. Interventional pain treatments are on the agenda for patients who cannot achieve effective pain palliation with conservative treatment. Since facet joints are innervated by the dorsal ramus, medial branch of the spinal nerves, medial branch blockade is applied in the treatment of facet-related pain. In cervical facet medial branch blockade, a mixture of local anesthetic and steroid is injected. Studies have found that adding steroids to local anesthetics increases injection effectiveness. Although there is no consensus on the type of steroid to be used, it is safer to use dexamethasone, a particle-free steroid, considering the dense vascular structure of the cervical region. However, the types of local anesthetic used in cervical facet medial branch blockade vary between studies. The type of local anesthetic used in cervical facet medial branch blockade in our clinic varies. There is only one study in the literature comparing local anesthetic types. Researchers compared the effectiveness of lidocaine and bupivacaine in cervical facet medial branch blockade without adding steroids. Researchers stated that lidocaine has a faster effect and longer duration of effect. Since there is no consensus on the type of local anesthetic, prilocaine or lidocaine is preferred in practice. This study aims to compare the effectiveness of lidocaine and prilocaine added to dexamethasone in cervical facet medial branch blockade, one of the routine treatment methods in our clinic.
Within the scope of the study, patients deemed suitable for cervical facet medial branch injection will be randomly numbered for prilocaine or lidocaine injection through the computer program. 57 patients will receive lidocaine + steroid injection, 57 patients will receive prilocaine + steroid injection. Cervical facet medial branch injections will be administered. The evaluations of the patients before and after the procedure will be recorded by the researcher who is blind to the procedure performed. Demographic information of the patients, including age, gender, comorbidities, pain duration, and facet injection level, will be recorded before the procedure. Before the procedure, pain intensity will be evaluated using the NRS 11 scale, and functionality will be evaluated using the Neck Disability Index (NDI). The amount of medication used by the patients (non-steroidal anti-inflammatory analgesics, opioids, muscle relaxants) will also be noted.
- Conditions
- Pain, Neck
- Being tested
- facet median block with prilocain, facet median block with lidocaine
- Keywords
- pain, nerve block
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
facet median block with prilocainProcedure or surgery
facet median block with prilocain
facet median block with lidocaineProcedure or surgery
facet median block with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| cervical faset median block with lidocaine | Active comparator | cervical faset median block with lidocaine Receives: Procedure: facet median block with lidocaine |
| cervical faset median block with prilocaine | Active comparator | cervical faset median block with prilocaine Receives: Procedure: facet median block with prilocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain intensity
Change from baseline in pain scores on the Numeric Rating Scale at 1 month in both groups
Measured: 1 month
change of participants functionality
Change of participants functionality (Neck Disability Score) at 1 month in both groups
Measured: 1 month
participants satisfaction
Participants satistification degree (satisfied", "uncertain" or "dissatisfied") at 1 month in both groups
Measured: 1 month
Secondary outcomes (2)
drug use in groups
the effect of lidocaine and prilocaine injection applied in addition to dexamethasone in cervical facet medial blockade on drug use.
Measured: 1 month
difference of drug use between groups
the effect of lidocaine and prilocaine injection applied in addition to dexamethasone in cervical facet medial blockade on drug use.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Gungor E Özgencil, Prof, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244667
- Sponsor's protocol ID
- 2023/468
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manchikanti L, Singh V, Falco FJ, Cash KM, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow-up. Spine (Phila Pa 1976). 2008 Aug 1;33(17):1813-20. doi: 10.1097/BRS.0b013e31817b8f88.
PubMed 18670333Manchikanti L, Sanapati MR, Pampati V, Soin A, Atluri S, Kaye AD, Subramanian J, Hirsch JA. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population. Pain Physician. 2020 Mar;23(2):E133-E149.
PubMed 32214289
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade
- ClinicalTrials.gov ID
- NCT06244667
- Acronym / sponsor ID
- 2023/468
- Conditions
- Pain, Neck
- Keywords
- pain, nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 6 Feb 2024 (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.
Neck pain is a common disease in society. In studies, the annual and lifetime prevalence was found to be 37.2% and 48.5%, respectively (1). Neck pain may be axial or radicular. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. (2) Cervical facet degeneration is a common cause of axial neck pain (3). Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. (2) Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved
Detailed description
Neck pain is a common disease in society. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. Cervical facet degeneration is a common cause of axial neck pain. Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved.
Conservative treatment methods for facet joint pain are medical treatment and various physical therapy modalities. Interventional pain treatments are on the agenda for patients who cannot achieve effective pain palliation with conservative treatment. Since facet joints are innervated by the dorsal ramus, medial branch of the spinal nerves, medial branch blockade is applied in the treatment of facet-related pain. In cervical facet medial branch blockade, a mixture of local anesthetic and steroid is injected. Studies have found that adding steroids to local anesthetics increases injection effectiveness. Although there is no consensus on the type of steroid to be used, it is safer to use dexamethasone, a particle-free steroid, considering the dense vascular structure of the cervical region. However, the types of local anesthetic used in cervical facet medial branch blockade vary between studies. The type of local anesthetic used in cervical facet medial branch blockade in our clinic varies. There is only one study in the literature comparing local anesthetic types. Researchers compared the effectiveness of lidocaine and bupivacaine in cervical facet medial branch blockade without adding steroids. Researchers stated that lidocaine has a faster effect and longer duration of effect. Since there is no consensus on the type of local anesthetic, prilocaine or lidocaine is preferred in practice. This study aims to compare the effectiveness of lidocaine and prilocaine added to dexamethasone in cervical facet medial branch blockade, one of the routine treatment methods in our clinic.
Within the scope of the study, patients deemed suitable for cervical facet medial branch injection will be randomly numbered for prilocaine or lidocaine injection through the computer program. 57 patients will receive lidocaine + steroid injection, 57 patients will receive prilocaine + steroid injection. Cervical facet medial branch injections will be administered. The evaluations of the patients before and after the procedure will be recorded by the researcher who is blind to the procedure performed. Demographic information of the patients, including age, gender, comorbidities, pain duration, and facet injection level, will be recorded before the procedure. Before the procedure, pain intensity will be evaluated using the NRS 11 scale, and functionality will be evaluated using the Neck Disability Index (NDI). The amount of medication used by the patients (non-steroidal anti-inflammatory analgesics, opioids, muscle relaxants) will also be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical faset median block with lidocaine | Active comparator | Procedure: facet median block with lidocainecervical faset median block with lidocaine |
| cervical faset median block with prilocaine | Active comparator | Procedure: facet median block with prilocaincervical faset median block with prilocaine |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20-79
- A history of axial cervical pain without radicular symptoms for at least 3 months
- NRS score of 4 and above
- Not having had a cervical interventional procedure in the last year
- Patients who cannot achieve adequate pain palliation with pharmacological and physical treatment modalities
Key exclusion criteria (8 listed)
- Patients experiencing cervical radicular pain due to disc herniation or foraminal stenosis and neck pain due to cervical canal stenosis
- Patients with previous cervical surgery
- Patients with psychiatric illnesses that are unstable/uncontrolled with medical treatment
- Pregnant patients
- Bleeding diathesis
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 |
|---|---|---|
| facet median block with prilocainfacet median block with prilocain | Procedure or surgery | cervical faset median block with prilocaine |
| facet median block with lidocainefacet median block with lidocaine | Procedure or surgery | cervical faset median block with lidocaine |
Primary outcome
change of pain intensity
Time frame: 1 month
Change from baseline in pain scores on the Numeric Rating Scale at 1 month in both groups
change of participants functionality
Time frame: 1 month
Change of participants functionality (Neck Disability Score) at 1 month in both groups
participants satisfaction
Time frame: 1 month
Participants satistification degree (satisfied", "uncertain" or "dissatisfied") at 1 month in both groups
2 secondary outcomes
drug use in groups
Time frame: 1 month
difference of drug use between groups
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 18670333Manchikanti L, Singh V, Falco FJ, Cash KM, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow-up. Spine (Phila Pa 1976). 2008 Aug 1;33(17):1813-20. doi: 10.1097/BRS.0b013e31817b8f88.
- Background: PubMed 32214289Manchikanti L, Sanapati MR, Pampati V, Soin A, Atluri S, Kaye AD, Subramanian J, Hirsch JA. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population. Pain Physician. 2020 Mar;23(2):E133-E149.
- Individual participant dataSharing planned: No
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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.
Gungor E Özgencil, Prof study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing facet median block with prilocain and facet median block with lidocaine in people with Pain, Neck, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain intensity (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244667, which also lists 2 linked publications.
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 6 Feb 2024.