Not provided
Not provided
Not provided
Not provided
Not provided
Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
"Does low-does cervical epidural lidocaine cause transient weakness?"
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical interlaminar with lidocaine | Procedure | Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline. | Strength Testing Dynamometry post procedure with lidocaine vs normal saline. | 30 minutes post-procedure |
| Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline. | Sensory Exam of upper extremity | 30 minutes post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure Changes | Mean Arterial Pressure | 30 minutes post-procedure |
| Heart Rate Changes | Heart Rate | 30 minutes post-procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zachary L McCormick, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17636629 | Background | 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. | |
| 8213020 | Background | Stav 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Interlaminar With Lidocaine | 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). cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine. Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure. Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. |
| FG001 | Cervical Interlaminar With Normal Saline | 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). cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Interlaminar With Lidocaine | 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). cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine. Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure. Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Dynamometer Testing Post Procedure With Lidocaine vs Normal Saline. | Strength Testing Dynamometry post procedure with lidocaine vs normal saline. | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | 30 minutes post-procedure |
|
Adverse event data was collected on each participant from their first day of enrollment until one month post procedure (Timeframe was approximately 1 1/2 months for each participant from enrollment, strength testing/procedure, to one month follow up). Duration of study enrollment was from December 20, 2017 to August 19, 2020 when study enrollment was closed.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Interlaminar With Lidocaine | 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). cervical interlaminar with lidocaine: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine. Lidocaine: 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure. Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure AE | Cardiac disorders | Non-systematic Assessment | AE for cardiac and unrelated to procedure. |
Not provided
Early termination leading to low enrollment which ended up being the greatest limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zachary McCormick | University of Utah, Department of Physical Medicine and Rehabilitation | 801-587-5432 | PMR.Research@hsc.utah.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2017 | Aug 19, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| D014222 | Triamcinolone Acetonide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
|
| cervical interlaminar with normal saline | Procedure | Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline |
|
|
| Lidocaine | Drug | 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure. |
|
|
| Triamcinolone Acetonide | Drug | 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. |
|
|
| Normal saline | Drug | 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar 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) | pre procedure, post-procedure, 1 day follow up, and one month follow up |
| Upper Extremity Functional Index | Upper Extremity Functional Index (UEFI) Questionnaire | pre procedure, post-procedure, 1 day follow up, and one month follow up |
| Pain Medication | Pain medication changes throughout treatment using MQS III calculator | 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 | one month follow up |
| 8516703 | Background | Ferrante 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. |
| 12736872 | Background | Botwin 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. |
| 3017152 | Background | Rowlingson JC, Kirschenbaum LP. Epidural analgesic techniques in the management of cervical pain. Anesth Analg. 1986 Sep;65(9):938-42. |
| 7816491 | Background | Castagnera 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. |
| 22024908 | Background | Lee 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. |
| 27922950 | Background | McCormick 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. |
| 9585292 | Background | Capdevila 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. |
| 14601282 | Background | Bansal 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. |
| 1317680 | Background | Collier 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. |
| 26065819 | Background | Plastaras 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. |
| 27871598 | Background | Ortiz 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. |
| 26854576 | Background | Gray 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. |
| 26684648 | Background | van 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. |
| 9014953 | Background | Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8. |
| 21319615 | Background | Bohannon RW. Grip strength impairments among older adults receiving physical therapy in a home-care setting. Percept Mot Skills. 2010 Dec;111(3):761-4. doi: 10.2466/03.10.15.PMS.111.6.761-764. |
| 11845146 | Background | Hayes K, Walton JR, Szomor ZL, Murrell GA. Reliability of 3 methods for assessing shoulder strength. J Shoulder Elbow Surg. 2002 Jan-Feb;11(1):33-9. doi: 10.1067/mse.2002.119852. |
| 17530541 | Background | Kolber MJ, Beekhuizen K, Cheng MS, Fiebert IM. The reliability of hand-held dynamometry in measuring isometric strength of the shoulder internal and external rotator musculature using a stabilization device. Physiother Theory Pract. 2007 Mar-Apr;23(2):119-24. doi: 10.1080/09593980701213032. |
| 27134388 | Background | Awatani T, Mori S, Shinohara J, Koshiba H, Nariai M, Tatsumi Y, Nagata A, Morikita I. Same-session and between-day intra-rater reliability of hand-held dynamometer measurements of isometric shoulder extensor strength. J Phys Ther Sci. 2016 Mar;28(3):936-9. doi: 10.1589/jpts.28.936. Epub 2016 Mar 31. |
| 26386839 | Background | Fieseler G, Molitor T, Irlenbusch L, Delank KS, Laudner KG, Hermassi S, Schwesig R. Intrarater reliability of goniometry and hand-held dynamometry for shoulder and elbow examinations in female team handball athletes and asymptomatic volunteers. Arch Orthop Trauma Surg. 2015 Dec;135(12):1719-26. doi: 10.1007/s00402-015-2331-6. Epub 2015 Sep 19. |
| 22330109 | Background | Kirshblum SC, Waring W, Biering-Sorensen F, Burns SP, Johansen M, Schmidt-Read M, Donovan W, Graves D, Jha A, Jones L, Mulcahey MJ, Krassioukov A. Reference for the 2011 revision of the International Standards for Neurological Classification of Spinal Cord Injury. J Spinal Cord Med. 2011 Nov;34(6):547-54. doi: 10.1179/107902611X13186000420242. |
| 24817380 | Background | Kim JK, Park MG, Shin SJ. What is the minimum clinically important difference in grip strength? Clin Orthop Relat Res. 2014 Aug;472(8):2536-41. doi: 10.1007/s11999-014-3666-y. Epub 2014 May 10. |
| BG001 | Cervical Interlaminar With Normal Saline | 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). cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cervical Interlaminar With Normal Saline | 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). cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. |
|
| Primary | Sensory Exam Testing Post Procedure With Lidocaine vs Normal Saline. | Sensory Exam of upper extremity | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | 30 minutes post-procedure |
|
|
| Secondary | Mean Arterial Blood Pressure Changes | Mean Arterial Pressure | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | 30 minutes post-procedure |
|
|
| Secondary | Heart Rate Changes | Heart Rate | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | 30 minutes post-procedure |
|
|
| Secondary | 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) | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | pre procedure, post-procedure, 1 day follow up, and one month follow up |
|
|
| Secondary | Upper Extremity Functional Index | Upper Extremity Functional Index (UEFI) Questionnaire | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | pre procedure, post-procedure, 1 day follow up, and one month follow up |
|
|
| Secondary | Pain Medication | Pain medication changes throughout treatment using MQS III calculator | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | pre procedure, post-procedure, 1 day follow up, and one month follow up |
|
|
| Secondary | Patient Global Impression of Change | 7 point question called Patient Global Impression of Change | Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained. | Posted | one month follow up |
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Cervical Interlaminar With Normal Saline | 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). cervical interlaminar with normal saline: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline Triamcinolone Acetonide: 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures. Normal saline: 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure. | 0 | 6 | 0 | 6 | 0 | 6 |
|
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |