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New method of pain control pushed by surgeons.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Controlled Analgesia | Active Comparator | 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. |
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| epidural Catheter | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Pain Scale Scores During 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. | Postoperative days 0-4 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Morphine Equivalent Consumption During 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Glover, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children't Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes |
| FG001 | 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. Hydromorphone: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age on day of surgery |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Verbal Pain Scale Scores During 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. | Pain scores could not be collected on each post-operative day because some subjects were discharged from the hospital quicker than others. | Posted | Mean | Standard Deviation | units on a scale | Postoperative days 0-4 |
|
Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Complications | Surgical and medical procedures | Non-systematic Assessment | Surgical complications requiring secondary surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epidural Related | Surgical and medical procedures | Non-systematic Assessment | Epidural Placement Failed or Epidural Dislodged and subject switched to IV PCA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Glover, MD, MBA | Baylor College of Medicine | 832-824-5800 | cdglover@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Apr 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Morphine | Drug | This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes |
|
| Postoperative days 0-4 |
| Rescue Morphine Equivalent Administration During 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. | Postoperative days 0-4 |
| Withdrawal by Subject |
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| Issues with epidural |
|
| BG001 | 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. Hydromorphone: 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. |
| BG002 | Total | Total of all reporting groups |
| Full Range |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA Status | The ASA Physical Status Classification System assesses a patient's pre-anesthesia medical co-morbidities. The scale ranges from 1 to 6 with lower scores indicating a healthier patient. This is measured during the pre-operative assessment. | Count of Participants | Participants |
|
| OG001 | 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. Hydromorphone: 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. |
|
|
| Secondary | Total Morphine Equivalent Consumption During 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. | Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others. | Posted | Mean | Standard Deviation | mg/kg | Postoperative days 0-4 |
|
|
|
| Secondary | Rescue Morphine Equivalent Administration During 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. | Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others. | Posted | Mean | Standard Deviation | mg/kg | Postoperative days 0-4 |
|
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| 0 |
| 33 |
| 1 |
| 33 |
| 3 |
| 33 |
| EG001 | 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. Hydromorphone: 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. | 0 | 29 | 0 | 29 | 3 | 29 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| ASA III |
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| ASA IV |
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| ASA V |
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| ASA VI |
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| Unknown |
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