Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

NCT ID: NCT03746951

Last Updated: 2022-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ropivacaine Hcl 0.5% Inj Vil 20Ml

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine Hcl 0.5% Inj Vil 20Ml

Intervention Type DRUG

Anesthetic agent used in peripheral nerve block

Interventions

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Ropivacaine Hcl 0.5% Inj Vil 20Ml

Anesthetic agent used in peripheral nerve block

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Senthil G. Krishna

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB18-01102

Identifier Type: -

Identifier Source: org_study_id

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