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Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746951
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Senthil G. Krishna, Nationwide Children's Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 : April 24, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Naropin




Primary Outcome Measures :
  1. Total time to perform the regional anesthesia technique [ Time Frame: Baseline ]
    The amount of time if takes to perform either the FICB or LPB.


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hours post-op ]
    Total amount of opioids required to control pain.

  2. Opioid consumption [ Time Frame: 48 hours post-op ]
    Total amount of opioids required to control pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746951


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Responsible Party: Senthil G. Krishna, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03746951    
Other Study ID Numbers: IRB18-01102
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents