A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair
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|ClinicalTrials.gov Identifier: NCT02056301|
Recruitment Status : Terminated (New method of pain control pushed by surgeons.)
First Posted : February 5, 2014
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pectus Excavatum||Drug: Hydromorphone Drug: Morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison Trial Between Patient Controlled Intravenous Analgesia (PCA) and Epidural Analgesia for Pectus Excavatum Repair|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||April 10, 2019|
|Actual Study Completion Date :||October 2019|
Active Comparator: Patient Controlled Analgesia
One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.
This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Active Comparator: epidural Catheter
The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.
In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
- Verbal Pain Scale Scores During Postoperative Days 0-4 [ Time Frame: Postoperative days 0-4 ]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 scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain.
- Total Morphine Equivalent Consumption During Postoperative Days 0-4 [ Time Frame: Postoperative days 0-4 ]This outcome measures total amount of morphine administered in mg/kg by post-operative day 0-4. This captures all standard of care opioids delivered via their assigned cohort route (Epidural vs. IV PCA). Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
- Rescue Morphine Equivalent Administration During Postoperative Days 0-4 [ Time Frame: Postoperative days 0-4 ]This outcome measures the amount of rescue morphine administered due to breakthrough pain in mg/kg by post-operative day 0-4. This captures additional opioids that were administered by a nurse through an IV. Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
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): NCT02056301
|United States, Texas|
|Texas Children't Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chris Glover, MD||Baylor College of Medicine|