Cervical RadiculopathyPhase 4NCT03382925
Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
A Phase 4 study testing cervical interlaminar with lidocaine, cervical interlaminar with normal saline and Lidocaine in people with Cervical Radiculopathy, run by University of Utah at 1 site in United States.
Trial summary
"Does low-does cervical epidural lidocaine cause transient weakness?" Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- cervical interlaminar with lidocaine, cervical interlaminar with normal saline and Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 19 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-80.
- Clinical diagnosis of cervical radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
- Patients who will undergo CESI for treatment of cervical radiculitis.
Who cannot join
- Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study.
- Inability to perform handgrip or arm strength testing.
- Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy).
- Current glucocorticoid use or ESI within past 6 months.
- Prior cervical spine surgery.
- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- Patient request for or requirement of conscious sedation for the injection procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
"Does low-does cervical epidural lidocaine cause transient weakness?"
Read the detailed description
Cervical radicular pain is relatively common, often treated with epidural steroid injection (ESI), when conservative treatments like oral analgesics, physical therapy, and activity modification have failed. There are no universal clinical practice guidelines for the use of diluents when CESI are performed.
Interlaminar CESI may be performed with or without the use of local anesthetics, due to training bias or theoretical concerns of weakness. CESI without the benefit of local anesthetic as a steroid diluent increases the latency of pain relief and may decrease diagnostic information immediately after a CESI with regard to pain generators responsible for symptoms, and may potentially decrease patient satisfaction.
By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI, we will enhance the safety of this treatment with regard to expectations of objective motor weakness as well as post procedure pain control in the recovery phase after the injection procedure.
Additionally, investigation of short-term pain, function, medication use, and global impression of change following use of local anesthetic versus saline as a diluent during interlaminar cervical ESI will provide evidence to inform the optimization of clinical outcomes related to steroid diluent choice.
- Conditions
- Cervical Radiculopathy
- Being tested
- cervical interlaminar with lidocaine, cervical interlaminar with normal saline, Lidocaine, Triamcinolone Acetonide, Normal saline
- Keywords
- cervical epidural steroid injection, local anesthetic, upper extremity weakness
- Medical subject headings
- Radiculopathy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical interlaminar with lidocaineProcedure or surgery
Also called cervical epidural steroid injection
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
cervical interlaminar with normal salineProcedure or surgery
Also called cervical epidural steroid injection
Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
LidocaineDrug
Also called Xylocaine
2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
Triamcinolone AcetonideDrug
Also called Kenalog
2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
Normal salineDrug
Also called sodium chloride
2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
| Study group | Role | What they receive |
|---|---|---|
| cervical interlaminar with lidocaine | Active comparator | Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL). Receives: Procedure: cervical interlaminar with lidocaine; Drug: Lidocaine; Drug: Triamcinolone Acetonide |
| cervical interlaminar with normal saline | Active comparator | Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL). Receives: Procedure: cervical interlaminar with normal saline; Drug: Triamcinolone Acetonide; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Measured: 30 minutes post-procedure
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Sensory Exam of upper extremity
Measured: 30 minutes post-procedure
Secondary outcomes (6)
Mean Arterial Blood Pressure Changes
Mean Arterial Pressure
Measured: 30 minutes post-procedure
Heart Rate Changes
Heart Rate
Measured: 30 minutes post-procedure
Pain Intensity
Pain intensity will be measured by a 0-10 scale called Numerical Rating Scale. (0 being no pain and 10 being worst pain)
Measured: pre procedure, post-procedure, 1 day follow up, and one month follow up
Upper Extremity Functional Index
Upper Extremity Functional Index (UEFI) Questionnaire
Measured: pre procedure, post-procedure, 1 day follow up, and one month follow up
Pain Medication
Pain medication changes throughout treatment using MQS III calculator
Measured: pre procedure, post-procedure, 1 day follow up, and one month follow up
Patient Global Impression of Change
7 point question called Patient Global Impression of Change
Measured: one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start20 Dec 2017
- Primary completion19 Aug 2019
- Study completion19 Aug 2020
Why it stopped: Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zack McCormick, University of Utah
- Investigators
- Zachary L McCormick, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382925
- Sponsor's protocol ID
- 106288
- Status last verified
- Nov 2022
- First submitted
- 4 Dec 2017
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peloso P, Gross A, Haines T, Trinh K, Goldsmith CH, Burnie S; Cervical Overview Group. Medicinal and injection therapies for mechanical neck disorders. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000319. doi: 10.1002/14651858.CD000319.pub4.
PubMed 17636629Stav A, Ovadia L, Sternberg A, Kaadan M, Weksler N. Cervical epidural steroid injection for cervicobrachialgia. Acta Anaesthesiol Scand. 1993 Aug;37(6):562-6. doi: 10.1111/j.1399-6576.1993.tb03765.x.
PubMed 8213020Ferrante FM, Wilson SP, Iacobo C, Orav EJ, Rocco AG, Lipson S. Clinical classification as a predictor of therapeutic outcome after cervical epidural steroid injection. Spine (Phila Pa 1976). 1993 May;18(6):730-6. doi: 10.1097/00007632-199305000-00010.
PubMed 8516703Botwin KP, Castellanos R, Rao S, Hanna AF, Torres-Ramos FM, Gruber RD, Bouchlas CG, Fuoco GS. Complications of fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 May;84(5):627-33. doi: 10.1016/s0003-9993(02)04862-1.
PubMed 12736872Rowlingson JC, Kirschenbaum LP. Epidural analgesic techniques in the management of cervical pain. Anesth Analg. 1986 Sep;65(9):938-42.
PubMed 3017152Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Senegas J. Long-term results of cervical epidural steroid injection with and without morphine in chronic cervical radicular pain. Pain. 1994 Aug;58(2):239-243. doi: 10.1016/0304-3959(94)90204-6.
PubMed 7816491Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.
PubMed 22024908McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521.
PubMed 27922950Capdevila X, Biboulet P, Rubenovitch J, Serre-Cousine O, Peray P, Deschodt J, d'Athis F. The effects of cervical epidural anesthesia with bupivacaine on pulmonary function in conscious patients. Anesth Analg. 1998 May;86(5):1033-8. doi: 10.1097/00000539-199805000-00024.
PubMed 9585292Bansal S, Turtle MJ. Inadvertent subdural spread complicating cervical epidural steroid injection with local anaesthetic agent. Anaesth Intensive Care. 2003 Oct;31(5):570-2. doi: 10.1177/0310057X0303100512.
PubMed 14601282Collier CB. Accidental subdural block: four more cases and a radiographic review. Anaesth Intensive Care. 1992 May;20(2):215-25. doi: 10.1177/0310057X9202000218. No abstract available.
PubMed 1317680Plastaras C, McCormick ZL, Garvan C, Macron D, Joshi A, Chimes G, Smeal W, Rittenberg J, Kennedy DJ. Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections. Spine J. 2015 Oct 1;15(10):2157-65. doi: 10.1016/j.spinee.2015.05.034. Epub 2015 Jun 9.
PubMed 26065819Ortiz MP, Godoy MC, Schlosser RS, Ortiz RP, Godoy JP, Santiago ES, Rigo FK, Beck V, Duarte T, Duarte MM, Menezes MS. Effect of endovenous lidocaine on analgesia and serum cytokines: double-blinded and randomized trial. J Clin Anesth. 2016 Dec;35:70-77. doi: 10.1016/j.jclinane.2016.07.021. Epub 2016 Aug 6.
PubMed 27871598Gray A, Marrero-Berrios I, Weinberg J, Manchikalapati D, SchianodiCola J, Schloss RS, Yarmush J. The effect of local anesthetic on pro-inflammatory macrophage modulation by mesenchymal stromal cells. Int Immunopharmacol. 2016 Apr;33:48-54. doi: 10.1016/j.intimp.2016.01.019. Epub 2016 Feb 6.
PubMed 26854576van der Wal SE, van den Heuvel SA, Radema SA, van Berkum BF, Vaneker M, Steegers MA, Scheffer GJ, Vissers KC. The in vitro mechanisms and in vivo efficacy of intravenous lidocaine on the neuroinflammatory response in acute and chronic pain. Eur J Pain. 2016 May;20(5):655-74. doi: 10.1002/ejp.794. Epub 2015 Dec 18.
PubMed 26684648
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
- ClinicalTrials.gov ID
- NCT03382925
- Acronym / sponsor ID
- 106288
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical epidural steroid injection, local anesthetic, upper extremity weakness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Does low-does cervical epidural lidocaine cause transient weakness?"
Detailed description
Cervical radicular pain is relatively common, often treated with epidural steroid injection (ESI), when conservative treatments like oral analgesics, physical therapy, and activity modification have failed. There are no universal clinical practice guidelines for the use of diluents when CESI are performed.
Interlaminar CESI may be performed with or without the use of local anesthetics, due to training bias or theoretical concerns of weakness. CESI without the benefit of local anesthetic as a steroid diluent increases the latency of pain relief and may decrease diagnostic information immediately after a CESI with regard to pain generators responsible for symptoms, and may potentially decrease patient satisfaction.
By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI, we will enhance the safety of this treatment with regard to expectations of objective motor weakness as well as post procedure pain control in the recovery phase after the injection procedure.
Additionally, investigation of short-term pain, function, medication use, and global impression of change following use of local anesthetic versus saline as a diluent during interlaminar cervical ESI will provide evidence to inform the optimization of clinical outcomes related to steroid diluent choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical interlaminar with lidocaine | Active comparator | Procedure: cervical interlaminar with lidocaine, Drug: Lidocaine, Drug: Triamcinolone AcetonideGroup #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL 1% lidocaine (total volume 4 mL). |
| cervical interlaminar with normal saline | Active comparator | Procedure: cervical interlaminar with normal saline, Drug: Triamcinolone Acetonide, Drug: Normal salineGroup #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone acetonide 80 mg (40 mg/mL) + 2 mL preservative saline (total volume 4 mL). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80.
- Clinical diagnosis of cervical radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
Key exclusion criteria (7 listed)
- Refusal to participate, provide consent, or provide communication and follow-up information for duration of the study.
- Inability to perform handgrip or arm strength testing.
- Contraindications to Cervical ESI (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for CIESI, and pregnancy).
- Current glucocorticoid use or ESI within past 6 months.
- Prior cervical spine surgery.
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 |
|---|---|---|
| cervical interlaminar with lidocaineAlso: cervical epidural steroid injectionInterlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine. | Procedure or surgery | cervical interlaminar with lidocaine |
| cervical interlaminar with normal salineAlso: cervical epidural steroid injectionInterlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline | Procedure or surgery | cervical interlaminar with normal saline |
| LidocaineAlso: Xylocaine2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure. | Drug | cervical interlaminar with lidocaine |
| Triamcinolone AcetonideAlso: Kenalog2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. | Drug | cervical interlaminar with lidocaine, cervical interlaminar with normal saline |
| Normal salineAlso: sodium chloride2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. | Drug | cervical interlaminar with normal saline |
Primary outcome
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline.
Time frame: 30 minutes post-procedure
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline.
Time frame: 30 minutes post-procedure
Sensory Exam of upper extremity
6 secondary outcomes
Mean Arterial Blood Pressure Changes
Time frame: 30 minutes post-procedure
Heart Rate Changes
Time frame: 30 minutes post-procedure
Pain Intensity
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Upper Extremity Functional Index
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Pain Medication
Time frame: pre procedure, post-procedure, 1 day follow up, and one month follow up
Patient Global Impression of Change
Time frame: one month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17636629Peloso P, Gross A, Haines T, Trinh K, Goldsmith CH, Burnie S; Cervical Overview Group. Medicinal and injection therapies for mechanical neck disorders. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000319. doi: 10.1002/14651858.CD000319.pub4.
- Background: PubMed 8213020Stav A, Ovadia L, Sternberg A, Kaadan M, Weksler N. Cervical epidural steroid injection for cervicobrachialgia. Acta Anaesthesiol Scand. 1993 Aug;37(6):562-6. doi: 10.1111/j.1399-6576.1993.tb03765.x.
- Background: PubMed 8516703Ferrante FM, Wilson SP, Iacobo C, Orav EJ, Rocco AG, Lipson S. Clinical classification as a predictor of therapeutic outcome after cervical epidural steroid injection. Spine (Phila Pa 1976). 1993 May;18(6):730-6. doi: 10.1097/00007632-199305000-00010.
- Background: PubMed 12736872Botwin KP, Castellanos R, Rao S, Hanna AF, Torres-Ramos FM, Gruber RD, Bouchlas CG, Fuoco GS. Complications of fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 May;84(5):627-33. doi: 10.1016/s0003-9993(02)04862-1.
- Background: PubMed 3017152Rowlingson JC, Kirschenbaum LP. Epidural analgesic techniques in the management of cervical pain. Anesth Analg. 1986 Sep;65(9):938-42.
- Background: PubMed 7816491Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Senegas J. Long-term results of cervical epidural steroid injection with and without morphine in chronic cervical radicular pain. Pain. 1994 Aug;58(2):239-243. doi: 10.1016/0304-3959(94)90204-6.
- Background: PubMed 22024908Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.
- Background: PubMed 27922950McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521.
- Background: PubMed 9585292Capdevila X, Biboulet P, Rubenovitch J, Serre-Cousine O, Peray P, Deschodt J, d'Athis F. The effects of cervical epidural anesthesia with bupivacaine on pulmonary function in conscious patients. Anesth Analg. 1998 May;86(5):1033-8. doi: 10.1097/00000539-199805000-00024.
- Background: PubMed 14601282Bansal S, Turtle MJ. Inadvertent subdural spread complicating cervical epidural steroid injection with local anaesthetic agent. Anaesth Intensive Care. 2003 Oct;31(5):570-2. doi: 10.1177/0310057X0303100512.
- Background: PubMed 1317680Collier CB. Accidental subdural block: four more cases and a radiographic review. Anaesth Intensive Care. 1992 May;20(2):215-25. doi: 10.1177/0310057X9202000218. No abstract available.
- Background: PubMed 26065819Plastaras C, McCormick ZL, Garvan C, Macron D, Joshi A, Chimes G, Smeal W, Rittenberg J, Kennedy DJ. Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections. Spine J. 2015 Oct 1;15(10):2157-65. doi: 10.1016/j.spinee.2015.05.034. Epub 2015 Jun 9.
- 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.
Zachary L McCormick, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cervical interlaminar with lidocaine, cervical interlaminar with normal saline and Lidocaine in people with Cervical Radiculopathy, run by University of Utah at 1 site in United States.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Nov 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline. (time frame: 30 minutes post-procedure). The study lists 2 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 NCT03382925, which also lists 23 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 25 Nov 2022.