Trial Outcomes & Findings for Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks (NCT NCT03746951)

NCT ID: NCT03746951

Last Updated: 2022-03-03

Results Overview

The amount of time if takes to perform either the FICB or LPB.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-03-03

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fascia Iliaca Compartment Block (FICB) n=8 Participants 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	Lumbar Plexus Block (LPB) n=7 Participants 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	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=8 Participants	7 Participants n=7 Participants	15 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Age, Continuous	14 years n=8 Participants	13 years n=7 Participants	13 years n=15 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	3 Participants n=7 Participants	6 Participants n=15 Participants
Sex: Female, Male Male	5 Participants n=8 Participants	4 Participants n=7 Participants	9 Participants n=15 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	8 participants n=8 Participants	7 participants n=7 Participants	15 participants n=15 Participants
Weight	63.7 kilograms n=8 Participants	45 kilograms n=7 Participants	59.7 kilograms n=15 Participants
Height	167.5 centimeters n=8 Participants	150.4 centimeters n=7 Participants	158 centimeters n=15 Participants

PRIMARY outcome

Timeframe: Baseline

The amount of time if takes to perform either the FICB or LPB.

Outcome measures

Measure	Fascia Iliaca Compartment Block (FICB) n=8 Participants 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	Lumbar Plexus Block (LPB) n=7 Participants 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
Total Time to Perform the Regional Anesthesia Technique	3 minutes Interval 3.0 to 6.0	6 minutes Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: Immediately to 1 hour post-op

Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).

Outcome measures

Measure	Fascia Iliaca Compartment Block (FICB) n=8 Participants 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	Lumbar Plexus Block (LPB) n=7 Participants 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
Opioid Consumption in the PACU	7 participants	5 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fascia Iliaca Compartment Block (FICB) n=8 Participants 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	Lumbar Plexus Block (LPB) n=7 Participants 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
Post-op Pain Scores	2.95 units on a scale Interval 0.0 to 8.0	3.78 units on a scale Interval 0.0 to 10.0

Adverse Events

Fascia Iliaca Compartment Block (FICB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumbar Plexus Block (LPB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Senthil Krishna

Nationwide Children's Hospital

Phone: 614-722-4200

Email: Senthil.Krishna@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place