Comparison · NCT01238536-sae
Epidural Steroid Injection vs Epidural Local Anesthetic Injection: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Epidural Steroid Injection vs Epidural Local Anesthetic Injection: serious adverse events. Trial comparisons, record NCT01238536-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01238536-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.025 | 0.0107 | 0.0572 | wilson | |
| Risk in group 2 | 0.02 | 0.0078 | 0.0503 | wilson | |
| Risk difference, group 1 minus group 2 | 0.005 | -0.0285 | 0.0394 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.341 | 4.59 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.332 | 4.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Epidural Steroid Injection than on Epidural Local Anesthetic Injection | 200 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Epidural Steroid Injection | Intervention: Epidural steroid with local anesthetic injection~2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)in an opaque syringe.~Epidural steroid with local anesthetic injection: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.~Epidural steroid injection: Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe. | 5 | 200 | EG000 |
| Group 2 | Epidural Local Anesthetic Injection | Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.~Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. | 4 | 200 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
- NCT number
- NCT01238536
- Phases
- PHASE4
- Conditions
- Spinal Stenosis, Low Back Pain
- Interventions
- Epidural steroid with local anesthetic injection, Epidural local anesthetic injection, Epidural steroid injection, Epidural local anesthetic injection
- Lead sponsor
- University of Washington
- Results first posted
- 2017-12-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01238536?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01238536-sae