Clinical trial NCT02056301: A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair
Official title: A Comparison Trial Between Patient Controlled Intravenous Analgesia (PCA) and Epidural Analgesia for Pectus Excavatum Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pectus Excavatum
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 62
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 mean pain score during postoperative days 0-4.

Detailed description: 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 opioids. It is unclear from published data which method is superior and different tertiary care centers in the USA have a preference for different methods.

Eligibility criteria: Inclusion Criteria:

* Patients age 8- 18 years 2) Patients undergoing minimally invasive pectus excavatum repair via Nuss procedure 3) American Society of Anesthesiology Status I-III

Exclusion Criteria:

* 1) Refusal of epidural catheter 2) Pregnancy 3) Bleeding History 4) Inability to understand how to use the PCA device 5) Medication interfering with blood coagulation 6) Patients allergic to local anesthetics 7) Patient refusal to participate in study 8) Developmental delay

Primary outcomes:
measure: Verbal Pain Scale Scores During Postoperative Days 0-4
timeFrame: Postoperative days 0-4
Secondary outcomes:
measure: Total Morphine Equivalent Consumption During Postoperative Days 0-4
timeFrame: Postoperative days 0-4
measure: Rescue Morphine Equivalent Administration During Postoperative Days 0-4
timeFrame: Postoperative days 0-4
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children't Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Chris Glover, MD
role: PRINCIPAL_INVESTIGATOR
References: