A Phase 2/3 interventional study of Ropivacaine Hcl 0.5% Inj Vil 20Ml in Orthopedic Disorder, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Nationwide Children's Hospital · Phase 2/3, Interventional, and Treatment
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.
668 studies on the registry are indexed under Musculoskeletal Diseases; 161 are open to participants now.
This study's enrollment of 15 is below the median of 73 across 442 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
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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.
Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml
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.
Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml
Anesthetic agent used in peripheral nerve block
Also known as: Naropin
Total Time to Perform the Regional Anesthesia Technique
The amount of time if takes to perform either the FICB or LPB.
Time frame: Baseline
Opioid Consumption in the PACU
Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).
Time frame: 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.
Time frame: 48 hours post-op
| Milestone | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
The amount of time if takes to perform either the FICB or LPB.
| minutes | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Total Time to Perform the Regional Anesthesia Technique | 3 (3 to 6) | 6 (4 to 11) |
Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).
| participants | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Opioid Consumption in the PACU | 7 | 5 |
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.
| units on a scale | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Post-op Pain Scores | 2.95 (0 to 8) | 3.78 (0 to 10) |
Collected over 48 hours post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Lumbar Plexus Block (LPB) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| <=18 years | 8 | 7 | 15 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Median | 14 (8 to 16) | 13 (7 to 16) | 13 (7 to 16) |
| Sex: Female, Male(Participants) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 5 | 4 | 9 |
| Race and Ethnicity Not Collected(Participants) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| United States | 8 | 7 | 15 |
| Weight(kilograms) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Median | 63.7 (25.3 to 90.7) | 45 (23 to 67.5) | 59.7 (27 to 75) |
| Height(centimeters) | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Median | 167.5 (118 to 179.7) | 150.4 (119.8 to 166.4) | 158 (122.7 to 177.1) |
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Studies of the drug tested here: Ropivacaine
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