Orthopedic Disorder
Conditions
Brief summary
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.
Interventions
DRUGRopivacaine Hcl 0.5% Inj Vil 20Ml
Anesthetic agent used in peripheral nerve block
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* ASA grade I-III * Undergoing elective orthopedic surgical procedures involving the hip and upper thigh
Exclusion criteria
* Local anesthetic allergy * Skin or localized infection at the site of catheter insertion * Patient or parent refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time to Perform the Regional Anesthesia Technique | Baseline | The amount of time if takes to perform either the FICB or LPB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in the PACU | Immediately to 1 hour post-op | Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU). |
| Post-op Pain Scores | 48 hours post-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Fascia Iliaca Compartment Block (FICB) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14 years | 13 years | 13 years |
| Height | 167.5 centimeters | 150.4 centimeters | 158 centimeters |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
| Weight | 63.7 kilograms | 45 kilograms | 59.7 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Total Time to Perform the Regional Anesthesia Technique
The amount of time if takes to perform either the FICB or LPB.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | Total Time to Perform the Regional Anesthesia Technique | 3 minutes |
| Lumbar Plexus Block (LPB) | Total Time to Perform the Regional Anesthesia Technique | 6 minutes |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | Opioid Consumption in the PACU | 7 participants |
| Lumbar Plexus Block (LPB) | Opioid Consumption in the PACU | 5 participants |
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.
Time frame: 48 hours post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | Post-op Pain Scores | 2.95 units on a scale |
| Lumbar Plexus Block (LPB) | Post-op Pain Scores | 3.78 units on a scale |