Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | August 1, 2018 |
| End Date: | January 15, 2022 |
| Contact: | David Walega, M.D. |
| Email: | d-walega@northwestern.edu |
| Phone: | 312-695-4052 |
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.
(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.
Control Group: Prospective observational cohort study of UE strength in pain clinic patients
undergoing trigger point injections and occipital nerve injections to serve as controls to
measure variability of strength testing before and 30 min after such an intervention.
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 (Control Cohort, 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.
undergoing trigger point injections and occipital nerve injections to serve as controls to
measure variability of strength testing before and 30 min after such an intervention.
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 (Control Cohort, 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.
Inclusion Criteria:
- All patients ages 18 years or older who will undergo CESI for treatment of cervical
radiculitis
Exclusion Criteria:
- Patient refusal
- Lack of consent
- Any contraindication to CESI
- Inability to communicate with staff or to participate in follow up
- Inability to perform handgrip or arm strength testing
- Cervical spinal cord lesions
- Cerebrovascular, demyelinating or other neuromuscular muscular disease
- Patient request for or requirement of conscious sedation for the injection procedure
- Pregnancy
- Breast feeding
- Sensitivity to amides
- History of allergy to local anesthetics
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Phone: 312-695-4052
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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