A Phase 4 interventional study of Hydromorphone and Morphine in Pectus Excavatum, sponsored by Baylor College of Medicine. Terminated at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Treatment
Among 22 studies in Funnel Chest with a site in United States — 2 open to participants now, 6 under way, none of them phase 3. Funnel Chest · United States.
Among the 22 studies in Funnel Chest with a site in United States, this one is the 8th largest by enrollment of the 13 interventional ones, is the only one that started in 2012, is one of 3 in phase 4, and was the 9th registered.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 62 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →2 of the 22 studies in Funnel Chest with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 9 Funnel Chest studies recruiting now, 1 (11%) set no upper age limit and 8 (89%) stop at 75 or younger; 9 take children under 18; 1 take healthy volunteers.
This study: 8 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2012.
Median enrollment 65 across the 13 interventional studies, 348 across the 9 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
None of the 22 has an industry lead sponsor. The 10 most frequent:
Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Baylor College of Medicine has 1 study filed under Funnel Chest — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Funnel Chest with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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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.
Drug: Morphine
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.
Drug: 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.
This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
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
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
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
| Milestone | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Started | 33 | 29 |
| Completed | 31 | 23 |
| Not completed | 2 | 6 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Surgical complications req. 2nd surgery | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Issues with epidural | 0 | 3 |
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.
| units on a scale | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Post-Operative Day 0 | 3.69 ± 1.98 | 2.28 ± 1.63 |
| Post-Operative Day 1 | 2.77 ± 2.19 | 1.11 ± 1.18 |
| Post-Operative Day 2 | 2.25 ± 1.65 | 2.14 ± 1.8 |
| Post-Operative Day 3 | 2.69 ± 1.33 | 2.73 ± 1.85 |
| Post-Operative Day 4 | 2.24 ± 1.52 | 2.14 ± 2.5 |
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.
| mg/kg | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Day 0 | 0.75 ± 0.34 | 0.14 ± 0.06 |
| Day 1 | 0.90 ± 0.42 | 0.23 ± 0.12 |
| Day 2 | 0.67 ± 0.33 | 0.61 ± 0.34 |
| Day 3 | 0.57 ± 0.36 | 0.92 ± 0.23 |
| Day 4 | 0.39 ± 0.32 | 0.45 ± 0.34 |
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.
| mg/kg | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Day 0 | 1.26 ± 0.89 | 0.57 ± 0.73 |
| Day 1 | 0.23 ± 0.67 | 0.26 ± 0.69 |
| Day 2 | 0.13 ± 0.50 | 0.70 ± 1.15 |
| Day 3 | 0.07 ± 0.26 | 0.39 ± 0.94 |
| Day 4 | 0.05 ± 0.23 | 0.10 ± 0.44 |
Collected over Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Controlled Analgesia | 0/33 (0%) | 1/33 (3%) | 3/33 (9.1%) |
| Epidural Catheter | 0/29 (0%) | 0/29 (0%) | 3/29 (10.3%) |
| Event | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Surgical ComplicationsSurgical and medical procedures | 1/33 | 0/29 |
| Event | Patient Controlled Analgesia | Epidural Catheter |
|---|---|---|
| Epidural RelatedSurgical and medical procedures | 3/33 | 3/29 |
| Age, Continuous(years) | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| Mean | 15.7 (12.6 to 17.7) | 16.0 (12.9 to 17.8) | 15.8 (12.6 to 17.8) |
| Sex/Gender, Customized(Participants) | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| Male | 26 | 21 | 47 |
| Female | 3 | 1 | 4 |
| Unknown | 2 | 1 | 3 |
| Race and Ethnicity Not Collected(Participants) | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| United States | 31 | 23 | 54 |
| ASA Status(Participants) | Patient Controlled Analgesia | Epidural Catheter | Total |
|---|---|---|---|
| ASA I | 8 | 7 | 15 |
| ASA II | 20 | 15 | 35 |
| ASA III | 1 | 0 | 1 |
| ASA IV | 0 | 0 | 0 |
| ASA V | 0 | 0 | 0 |
| ASA VI | 0 | 0 | 0 |
| Unknown | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Aug 2012, a primary completion of Apr 2019 and a completion of Oct 2019. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2020, 1 year 2 months after primary completion.
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This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydromorphone