Clinical Trial: A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparison Trial Between Patient Controlled Intravenous Analgesia (PCA) and Epidural Analgesia for Pectus Excavatum Repair

Brief Summary: The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the difference in pain scores at rest and with activity (coughing, deep breathing and movement) during postoperative days 1 -5.

Detailed Summary: Pectus excavatum is a cartilaginous deformity that is the most common congenital anterior chest wall defect in children [1]. Children with this disease process often complain of dyspnea, decreased exercise tolerance, and shortness of breath implying a restrictive pulmonary deficit [2]. Besides the reported physical limitations, patients can also exhibit manifestations of psychological disturbances (poor body image and depression). Surgical repair has been correlated with enhanced quality of life and improvement in body image[3] with recent studies showing improved pulmonary function and cardiac output [4, 5]. Surgery initially introduced by Sauerbruch involved rib cartilage resection and sternal osteotomy. This open procedure was further modified and became [6] known as the Ravitch procedure. This was the mainstay for repair for over 40 years until the introduction of minimally invasive surgery without rib resection by Nuss and colleagues in 1987 [7]. The Nuss repair involves placing an intrathoracic brace through small lateral chest wall incisions aided by thoracoscopy. Similar to bracing the teeth, the Nuss procedure avoids osteotomy or rib cartilage resection [8]. The Nuss procedure is the most common minimally invasive procedure in use today to correct this condition and is the current standard of surgical practice. Complications from Nuss repair can range anywhere from 7% to 25% [9] and can occur for as long as the bar is in place. Pain control remains a major issue in the perioperative period as patients may require weeks to months of oral narcotics before becoming pain-free after correction of the pectus. A prospective multicenter study reported peak pain scores of 8 on a 0-10 scale in the postoperative period and a mean score of 3 at discharge [4]. Postoperative pain after pectus repair has been managed with IV opioids administered by patient controlled analgesia (PCA) devices and by thoracic epidural infusions of combinations of local anesthetics and opioid
Sponsor: Baylor College of Medicine

Current Primary Outcome: Efficacy of epidural and IV analgesia in controlling pain [ Time Frame: May 1, 2014 ]

The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the difference in pain scores at rest and with activity (coughing, deep breathing and movement) during postoperative days 1 -5.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baylor College of Medicine

Dates:
Date Received: February 4, 2014
Date Started: August 2012
Date Completion: August 2017
Last Updated: September 23, 2016
Last Verified: September 2016