Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03746951
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks for Pain Management After Orthopedic Surgical Procedures Involving Hip and Femur in Pediatrics.
• Actual Study Start Date: Apr 24, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml; Anesthetic agent used in peripheral nerve block; Other Names: Naropin
Active Comparator: 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.	Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml; Anesthetic agent used in peripheral nerve block; Other Names: Naropin

Outcome Measures

Primary Outcome Measures

1. Total Time to Perform the Regional Anesthesia Technique [Baseline]

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

Secondary Outcome Measures

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 6, 2019

More Information

Publications

None provided.

• Responsible Party: Senthil G. Krishna, Attending Anesthesiologist, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT03746951
• Other Study ID Numbers: IRB18-01102
• First Posted: Nov 20, 2018
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Musculoskeletal Diseases; Ropivacaine

Study Results

Participant Flow

Arm/Group Title	Fascia Iliaca Compartment Block (FICB)	Lumbar Plexus Block (LPB)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fascia Iliaca Compartment Block (FICB)	Lumbar Plexus Block (LPB)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	8	7	15
Age (Count of Participants)
<=18 years	8 100%	7 100%	15 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	14	13	13
Sex: Female, Male (Count of Participants)
Female	3 37.5%	3 42.9%	6 40%
Male	5 62.5%	4 57.1%	9 60%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%	7 100%	15 100%
Weight (kilograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kilograms]	63.7	45	59.7
Height (centimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [centimeters]	167.5	150.4	158

Outcome Measures

1. Primary Outcome

Title	Total Time to Perform the Regional Anesthesia Technique
Description	The amount of time if takes to perform either the FICB or LPB.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fascia Iliaca Compartment Block (FICB)	Lumbar Plexus Block (LPB)
Arm/Group Description	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	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
Measure Participants	8	7
Median (Inter-Quartile Range) [minutes]	3	6

2. Secondary Outcome

Title	Opioid Consumption in the PACU
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fascia Iliaca Compartment Block (FICB)	Lumbar Plexus Block (LPB)
Arm/Group Description	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	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
Measure Participants	8	7
Number [participants]	7 87.5%	5 71.4%

3. Secondary Outcome

Title	Post-op Pain Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fascia Iliaca Compartment Block (FICB)	Lumbar Plexus Block (LPB)
Arm/Group Description	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	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
Measure Participants	8	7
Median (Inter-Quartile Range) [units on a scale]	2.95	3.78

Adverse Events

Time Frame	48 hours post-op
Arm/Group Title	Fascia Iliaca Compartment Block (FICB)		Lumbar Plexus Block (LPB)
Arm/Group Description	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		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
All Cause Mortality
	Fascia Iliaca Compartment Block (FICB)		Lumbar Plexus Block (LPB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Serious Adverse Events
	Fascia Iliaca Compartment Block (FICB)		Lumbar Plexus Block (LPB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Fascia Iliaca Compartment Block (FICB)		Lumbar Plexus Block (LPB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.