Pectus Excavatum
Conditions
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.
Interventions
DRUGHydromorphone
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.
DRUGMorphine
This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Scale Scores During Postoperative Days 0-4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Morphine Equivalent Consumption During Postoperative Days 0-4 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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. | 23 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Issues with epidural | 0 | 3 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Surgical complications req. 2nd surgery | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| Age, Continuous | 15.7 years | 16.0 years | 15.8 years |
| ASA Status ASA I | 8 Participants | 7 Participants | 15 Participants |
| ASA Status ASA II | 20 Participants | 15 Participants | 35 Participants |
| ASA Status ASA III | 1 Participants | 0 Participants | 1 Participants |
| ASA Status ASA IV | 0 Participants | 0 Participants | 0 Participants |
| ASA Status ASA V | 0 Participants | 0 Participants | 0 Participants |
| ASA Status ASA VI | 0 Participants | 0 Participants | 0 Participants |
| ASA Status Unknown | 2 Participants | 1 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 31 participants | 23 participants | 54 participants |
| Sex/Gender, Customized Female | 3 Participants | 1 Participants | 4 Participants |
| Sex/Gender, Customized Male | 26 Participants | 21 Participants | 47 Participants |
| Sex/Gender, Customized Unknown | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 29 |
| other Total, other adverse events | 3 / 33 | 3 / 29 |
| serious Total, serious adverse events | 1 / 33 | 0 / 29 |
Outcome results
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.
Time frame: Postoperative days 0-4
Population: Pain scores could not be collected on each post-operative day because some subjects were discharged from the hospital quicker than others.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Controlled Analgesia | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 1 | 2.77 units on a scale | Standard Deviation 2.19 |
| Patient Controlled Analgesia | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 3 | 2.69 units on a scale | Standard Deviation 1.33 |
| Patient Controlled Analgesia | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 2 | 2.25 units on a scale | Standard Deviation 1.65 |
| Patient Controlled Analgesia | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 4 | 2.24 units on a scale | Standard Deviation 1.52 |
| Patient Controlled Analgesia | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 0 | 3.69 units on a scale | Standard Deviation 1.98 |
| Epidural Catheter | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 4 | 2.14 units on a scale | Standard Deviation 2.5 |
| Epidural Catheter | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 0 | 2.28 units on a scale | Standard Deviation 1.63 |
| Epidural Catheter | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 1 | 1.11 units on a scale | Standard Deviation 1.18 |
| Epidural Catheter | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 2 | 2.14 units on a scale | Standard Deviation 1.8 |
| Epidural Catheter | Verbal Pain Scale Scores During Postoperative Days 0-4 | Post-Operative Day 3 | 2.73 units on a scale | Standard Deviation 1.85 |
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.
Time frame: Postoperative days 0-4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Controlled Analgesia | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 1 | 0.23 mg/kg | Standard Deviation 0.67 |
| Patient Controlled Analgesia | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 3 | 0.07 mg/kg | Standard Deviation 0.26 |
| Patient Controlled Analgesia | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 2 | 0.13 mg/kg | Standard Deviation 0.5 |
| Patient Controlled Analgesia | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 4 | 0.05 mg/kg | Standard Deviation 0.23 |
| Patient Controlled Analgesia | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 0 | 1.26 mg/kg | Standard Deviation 0.89 |
| Epidural Catheter | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 4 | 0.10 mg/kg | Standard Deviation 0.44 |
| Epidural Catheter | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 0 | 0.57 mg/kg | Standard Deviation 0.73 |
| Epidural Catheter | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 1 | 0.26 mg/kg | Standard Deviation 0.69 |
| Epidural Catheter | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 2 | 0.70 mg/kg | Standard Deviation 1.15 |
| Epidural Catheter | Rescue Morphine Equivalent Administration During Postoperative Days 0-4 | Day 3 | 0.39 mg/kg | Standard Deviation 0.94 |
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.
Time frame: Postoperative days 0-4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Controlled Analgesia | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 1 | 0.90 mg/kg | Standard Deviation 0.42 |
| Patient Controlled Analgesia | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 3 | 0.57 mg/kg | Standard Deviation 0.36 |
| Patient Controlled Analgesia | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 2 | 0.67 mg/kg | Standard Deviation 0.33 |
| Patient Controlled Analgesia | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 4 | 0.39 mg/kg | Standard Deviation 0.32 |
| Patient Controlled Analgesia | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 0 | 0.75 mg/kg | Standard Deviation 0.34 |
| Epidural Catheter | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 4 | 0.45 mg/kg | Standard Deviation 0.34 |
| Epidural Catheter | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 0 | 0.14 mg/kg | Standard Deviation 0.06 |
| Epidural Catheter | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 1 | 0.23 mg/kg | Standard Deviation 0.12 |
| Epidural Catheter | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 2 | 0.61 mg/kg | Standard Deviation 0.34 |
| Epidural Catheter | Total Morphine Equivalent Consumption During Postoperative Days 0-4 | Day 3 | 0.92 mg/kg | Standard Deviation 0.23 |