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Completed

NCT Number: NCT03746951

Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

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.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine Hcl 0.5% Inj Vil 20Ml

Drug

Anesthetic agent used in peripheral nerve block

Other names: Naropin

Primary outcomes

  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 outcomes

  1. Opioid Consumption in the PACU

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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