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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 and patient satisfaction in the recovery phase after the injection procedure.
Research Question:
Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength following cervical epidural steroid injection in patients being treated for cervical radiculitis?
Null Hypothesis:
Cervical epidural steroid injections that include local anesthetic as a diluent have no effect on objective upper extremity strength following the injection.
We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength in functional movements of the upper extremity.
Experimental Groups: Prospective, randomized, controlled, double blinded trial in patients undergoing CESI for symptoms of cervical radiculitis.
Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc).
Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc).
Adults who are eligible to have a CESI with triamcinolone for treatment of cervical radiculitis at the Northwestern Anesthesiology Pain Medicine Center will be approached by authorized research personnel prior to a patient's CESI is performed and will obtain informed consent from patients who agree to participate.
In every subject (Group 1 and Group 2) a pre-procedure NRS pain score, and presence of subjective or objective symptoms of UE weakness will be recorded. Bilateral handgrip, wrist extension, elbow flexion, and elbow extension strength (myotomes C5-T1) will be measured by a trained research assistant prior to the injection procedure using a handheld JAMAR® PLUS+ digital dynamometer (Sammons Preston, Bollingbrook, IL) for hand grip strength and a push/pull handheld hydraulic dynamometer (Balego and Associates Inc., St. Paul, MN) for arm strength assessment. Three baseline strength measurements will be recorded for each strength test. Measurements will be taken prior to and 30 minutes following the injection procedure. Patients in Group #1 and Group #2 will also be queried with the Upper Extremity Functional Index (UEFI) before the injection procedure and again 1 day after the procedure (administered via telephone).
For Group 1 and Group 2, patients will be randomized to treatment group based on a random computer-generated schedule. Participants will be blinded to the group to which they are randomized. All standard procedures for CESIs will be followed as is standard practice including time out, skin prep, hemodynamic monitoring, image guidance etc.
Per randomization, triamcinolone acetonide 80 mg (Kenalog) (E. R. Squibb & Sons Limited, Uxbridge UK) will be combined with 2mL Lidocaine 1% or 2 mL preservative free saline and will be injected during the CESI procedure. In all cases, the total injectate volume will be 4 mL in all cases. All injections will be image guided with fluoroscopy, as is the current standard practice. Fluoroscopy time will be recorded.
The participant will be discharged from the clinic with written discharge instructions (current standard practice).
Participants will be telephoned by clinic personnel 1 day after the CESI to assess for subjective weakness in the hands or arms as well as any other adverse reactions. As above, the Upper Extremity Functional Index will be administered at this time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Active Comparator | Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) |
|
| Experimental Group 2 | Placebo Comparator | Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group 1 triamcinolone and lidocaine | Drug | Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Strength in Both Groups After CESI. | Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer. | 30 minutes after the CESI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pain Reduction Post Procedure | A greater than or equal to 50% reduction in change in average pain score before and after the CESI procedure. | 30 minutes after the CESI procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Walega, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | 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. |
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159 subjects were assessed for eligibility. 27 declined to participate. 2 could not perform pre-study strength testing. 7 requested sedation for the injection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group 1 | Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) |
| FG001 | Experimental Group 2 | Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group 1 With Lidocaine | Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Strength in Both Groups After CESI. | Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer. | Posted | Count of Participants | Participants | 30 minutes after the CESI procedure |
|
24 hours after the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group 1 With Lidocaine | Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Vasovagal response |
Post procedural strength was not assessed beyond 30 minutes. Pain and pain-related outcomes are subjective and variable. It may have been beneficial to have a global impression of change (PGIC)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul C. Fitzgerald RN, BSN, MS | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| 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 | May 17, 2019 | Apr 14, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Prospective Randomized Controlled Trial using control arm plus 2 arm experimental (placebo and active drug)
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Participant will be blinded to group assignment. Outcome assessor will also be blinded to the randomization.
|
| Experimental Group 2 triamcinolone and saline | Drug | Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) |
|
|
| 2520395 | Background | Cicala RS, Thoni K, Angel JJ. Long-term results of cervical epidural steroid injections. Clin J Pain. 1989 Jun;5(2):143-5. doi: 10.1097/00002508-198906000-00003. |
| 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. |
| 32784231 | Derived | McCormick ZL, Burnham T, Cunningham S, Kendall RW, Bougie D, Teramoto M, Walega DR. Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):767-773. doi: 10.1136/rapm-2020-101598. Epub 2020 Aug 11. |
| Post procedure testing could not be obtained |
|
| BG001 | Experimental Group 2 With Saline | Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | BMI (kg/m^2) |
|
| Number of Participants with radicular pain based on myotome location | Radicular pain based on the location of the myotome determined by the physician. (grouping of muscles controlled by a single nerve). | Count of Participants | Participants |
|
| Numerical rating score(NRS) for pain | NRS is an 11 point pain scale where 0 is no pain (good) and 10 is worst pain imaginable (poor) | Mean | Standard Deviation | score on a scale |
|
| Number of participants with unilateral or bilateral symptoms | Laterally of the symptoms in percent frequency. Unilateral (one sided) or bilateral (both side) before treatment . | Number | participants |
|
| Physical exam- weakness in any myotome, freq (%) | Number | participants |
|
|
|
|
| Secondary | Number of Participants With Pain Reduction Post Procedure | A greater than or equal to 50% reduction in change in average pain score before and after the CESI procedure. | Patients whose baseline and post-NRS scores were both zero were excluded from this analysis. | Posted | Count of Participants | Participants | No | 30 minutes after the CESI procedure. |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 6 |
| 60 |
| EG001 | Experimental Group 2 With Saline | Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc) | 0 | 60 | 0 | 60 | 7 | 60 |
|
| Cardiac rhythm changes | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Change in heart rate patern |
|
| Pain at injection site | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Pain at the injection site where the needle was placed. |
|
| Paraesthesia/numbness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Numbness in the hands after the procedure. |
|
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| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |