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Completed

NCT Number: NCT02009267

Nuss Procedure: Clinical Options in Pediatric Pain Management?

A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

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

  • Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.

Exclusion criteria

  • None

Treatment and study plan

Patient controlled analgesia

Device

A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.

Continuous thoracic epidural infusions

Procedure

Continuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord.

Continuous paravertebral blockade

Procedure

Continuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.

Primary outcomes

  1. Total morphine dose

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Total morphine dose will be evaluated in mg/kg/24 hour period, beginning with post-op day 0 until discharge from the hospital.

Secondary outcomes

  1. Pain score

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

    Pain scores obtained from the visual analog scale.

  2. Length of hospitalization

    Time frame: Within the first week after surgery.

    Determine if there is a difference in length of hospitalization, and time to discharge.

  3. Nausea and vomiting

    Time frame: 0-48 hrs. post-op

    Determine the incidence of nausea and vomiting measured by the postoperative ondansetron dosing, beginning with arrival to floor and up to the first 48 hrs of hospitalization.

Sponsors and collaborators

Lead sponsor

Ralph Beltran

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2013
Registry last updated
Feb 2, 2017

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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