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| Name | Class |
|---|---|
| Rothman Institute Orthopaedics | OTHER |
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The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain.
Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22-Gauge Arm | Active Comparator | Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle |
|
| 25-Gauge Arm | Active Comparator | Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22-gauge needle | Device | 22-gauge Quincke needle used for epidural injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intravascular Uptake | The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Pain | Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain | During the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Raju, DO | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32883241 | Derived | Raju R, Mehnert M, Stolzenberg D, Simon J, Conliffe T, Gehret J. Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial. BMC Anesthesiol. 2020 Sep 3;20(1):222. doi: 10.1186/s12871-020-01137-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 22-Gauge Arm | Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle 22-gauge needle: 22-gauge Quincke needle used for epidural injection |
| FG001 | 25-Gauge Arm | Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle 25-gauge needle: 25-gauge Quincke needle used for epidural injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 22-Gauge Arm | Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle 22-gauge needle: 22-gauge Quincke needle used for epidural injection |
| BG001 | 25-Gauge Arm |
| 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 | Intravascular Uptake | The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature. | Posted | Mean | 95% Confidence Interval | percentage of total number of needle | During the procedure |
|
Each participant was assessed for adverse events within 1 month after the injection date.
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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 | 22-Gauge Arm | Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle 22-gauge needle: 22-gauge Quincke needle used for epidural injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Raju | Yale University | 203-688-8800 | robin.raju@yale.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 | Feb 1, 2018 | Jun 21, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2018 | Jun 21, 2020 | ICF_003.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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This was a prospective single blind randomized clinical trial.
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Randomization was done separately for each provider based on a computer generated algorithm. Patients were blinded to the gauge of the needle used for the procedure.
| 25-gauge needle | Device | 25-gauge Quincke needle used for epidural injection |
|
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 | Number | participants |
|
| 22-Gauge Arm |
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle 22-gauge needle: 22-gauge Quincke needle used for epidural injection |
| OG001 | 25-Gauge Arm | Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle 25-gauge needle: 25-gauge Quincke needle used for epidural injection |
|
|
| Secondary | Patient Reported Pain | Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain | Average NRS during the initial needle entry | Posted | Mean | 95% Confidence Interval | score on a scale | During the procedure |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | 25-Gauge Arm | Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle 25-gauge needle: 25-gauge Quincke needle used for epidural injection | 0 | 78 | 0 | 78 | 0 | 78 |
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