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The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing orthopedic procedures involving the hip or upper femur. This study will help determine the efficacy of the two techniques and their advantages when compared to each other including time to perform the block, opioid consumption reduction, effects on postoperative pain, and the length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fascia iliaca compartment block (FICB) | Active Comparator | FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin. |
|
| Lumbar plexus block (LPB) | Active Comparator | LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine Hcl 0.5% Inj Vil 20Ml | Drug | Anesthetic agent used in peripheral nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Time to Perform the Regional Anesthesia Technique | The amount of time if takes to perform either the FICB or LPB. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption in the PACU | Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU). | Immediately to 1 hour post-op |
| Post-op Pain Scores | Pain scores during the post-operative recovery period. Pain score scale is 0-10 with 0 being no pain and 10 being worst pain imaginable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fascia Iliaca Compartment Block (FICB) | FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block |
| FG001 | Lumbar Plexus Block (LPB) | LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fascia Iliaca Compartment Block (FICB) | FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block |
| BG001 |
| 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 | Total Time to Perform the Regional Anesthesia Technique | The amount of time if takes to perform either the FICB or LPB. | Posted | Median | Inter-Quartile Range | minutes | Baseline |
|
48 hours post-op
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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 | Fascia Iliaca Compartment Block (FICB) | FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Senthil Krishna | Nationwide Children's Hospital | 614-722-4200 | Senthil.Krishna@nationwidechildrens.org |
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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 6, 2019 | Feb 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| 48 hours post-op |
| Lumbar Plexus Block (LPB) |
LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | 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 |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
|
|
| Secondary | Opioid Consumption in the PACU | Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU). | Posted | Number | participants | Immediately to 1 hour post-op |
|
|
|
| Secondary | Post-op Pain Scores | Pain scores during the post-operative recovery period. Pain score scale is 0-10 with 0 being no pain and 10 being worst pain imaginable. | Posted | Median | Inter-Quartile Range | units on a scale | 48 hours post-op |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Lumbar Plexus Block (LPB) | LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back. Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block | 0 | 7 | 0 | 7 | 0 | 7 |
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| D000588 |
| Amines |