Trial Outcomes & Findings for Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness? (NCT NCT03382925)
NCT ID: NCT03382925
Last Updated: 2022-11-25
Results Overview
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
TERMINATED
PHASE4
16 participants
30 minutes post-procedure
2022-11-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cervical Interlaminar With Lidocaine
n=10 Participants
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.
|
Cervical Interlaminar With Normal Saline
n=6 Participants
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-procedurePopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Strength Testing Dynamometry post procedure with lidocaine vs normal saline.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 minutes post-procedurePopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Sensory Exam of upper extremity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutes post-procedurePopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Mean Arterial Pressure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutes post-procedurePopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Heart Rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre procedure, post-procedure, 1 day follow up, and one month follow upPopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Pain intensity will be measured by a 0-10 scale called Numerical Rating Scale. (0 being no pain and 10 being worst pain)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre procedure, post-procedure, 1 day follow up, and one month follow upPopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Upper Extremity Functional Index (UEFI) Questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre procedure, post-procedure, 1 day follow up, and one month follow upPopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
Pain medication changes throughout treatment using MQS III calculator
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one month follow upPopulation: Data was not collected. Study terminated early due to low enrollment. Zero participants completed both arms requirements. No statistical analysis obtained.
7 point question called Patient Global Impression of Change
Outcome measures
Outcome data not reported
Adverse Events
Cervical Interlaminar With Lidocaine
Cervical Interlaminar With Normal Saline
Serious adverse events
| Measure |
Cervical Interlaminar With Lidocaine
n=10 participants at risk
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.
|
Cervical Interlaminar With Normal Saline
n=6 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Procedure AE
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Zachary McCormick
University of Utah, Department of Physical Medicine and Rehabilitation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place