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| Name | Class |
|---|---|
| Halyard Health | INDUSTRY |
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Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced posteriorly. In severe cases, surgery is performed to correct the defect. In recent years, minimally invasive surgery with the placement of stainless steel support bars has been increasingly performed in patients over the age of 17 years. Because of the decreased malleability and tremendous pressure required to hold the chest wall in the corrected position, post-operative pain control has been a significant problem in this patient population. Thoracic epidurals are commonly employed however mean hospitalizations of up to 7 days have been required before adequate pain control on oral analgesics is obtained and patients are suitable for discharge.
It is hypothesized that using the ON-Q system (I-Flow Corporation, Lake Forest CA) with bilateral intercostal catheter infusion would provide adequate post operative pain control with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of narcotics for 1 week following surgery would also be less with the ON-Q system versus epidural.
Subjects meeting eligibility criteria were randomized to one of two arms for postoperative pain control: the On-Q system versus epidural. All subjects had additional pain management as per standardized protocol including subject controlled intravenous analgesia with morphine equivalent narcotics for a maximum of 48 hours at which time the subject was transitioned to oral pain medications. Subjects using less than 5 mg of Morphine in the first 24 hours after surgery were transitioned to oral pain medications at 24 hours. After transition to oral analgesia, subjects with continued pain assessment greater than 5 were administered intravenous morphine equivalents by nursing staff until pain assessments were less than 5.
ON-Q catheters could have been maintained for up to 6 days. Discharge of subjects with catheters in place was planned. The catheter was removed in the out-patient clinic if the subject was discharged before the 6th day. Subjects with epidural had their epidural discontinued at 72 hours.
Data was recorded for each subject by site personnel while the subjects remained hospitalized, but were recorded in a journal by subjects after discharge up to postoperative day 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic epidural | Active Comparator | Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team. |
|
| ON-Q soaker catheter system | Experimental | ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. Catheters will be removed by the surgeon in the hospital or clinic on the 6th post operative day. Patients may request removal of the catheter prior to the 6th day and this will not be considered a withdrawal from the study or complication and will be included in overall analysis, but noted accordingly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ON-Q soaker catheter system | Device | ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. Catheters will be removed by the surgeon in the hospital or clinic on the 6th post operative day. Patients may request removal of the catheter prior to the 6th day and this will not be considered a withdrawal from the study or complication and will be included in overall analysis, but noted accordingly. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11. | Up to 11 days post operation |
| Use of Analgesic Narcotic | Postoperative analgesic used each day over 7 day postoperative period. | 1-7 days post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Pain Score | Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn E Jaroszewski, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27621865 | Result | Jaroszewski DE, Temkit M, Ewais MM, Luckritz TC, Stearns JD, Craner RC, Gaitan BD, Ramakrishna H, Thunberg CA, Weis RA, Myers KM, Merritt MV, Rosenfeld DM. Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults. J Thorac Dis. 2016 Aug;8(8):2102-10. doi: 10.21037/jtd.2016.06.62. |
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Subjects were recruited from Mayo Clinic in Phoenix, Arizona.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thoracic Epidural | Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team. |
| FG001 | ON-Q Soaker Catheter System | ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are provided for subjects who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Thoracic Epidural | Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team. |
| BG001 | ON-Q Soaker Catheter System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hospital Length of Stay | Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11. | Posted | Mean | Standard Deviation | days | Up to 11 days post operation |
|
Adverse event reports were collected from the day of the operation up to postoperative day 7.
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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 | Thoracic Epidural | Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn E. Jaroszewski | Mayo Clinic | 480-301-7865 | Jaroszewski.Dawn@mayo.edu |
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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 |
|---|---|
| D007268 | Injections, Epidural |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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|
| Epidural (ropivicaine 0.25%) | Drug | Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team. |
|
|
| Days 1-7 post operation |
ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Use of Analgesic Narcotic | Postoperative analgesic used each day over 7 day postoperative period. | The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). The protocol had planned to use the area under the curve, but this was not analyzed in the published paper, due to the presence of missing data in the analgesic narcotic measurements. | Posted | Mean | Standard Deviation | morphine milligram equivalents | 1-7 days post operation |
|
|
|
|
| Secondary | Mean Daily Pain Score | Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged. | The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). | Posted | Mean | Standard Deviation | units on a scale | Days 1-7 post operation |
|
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | ON-Q Soaker Catheter System | ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. | 0 | 55 | 11 | 55 |
| Pleural effusion requiring thoracentesis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax requiring chest tube | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary retention requiring catheter placement | Renal and urinary disorders | Systematic Assessment |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013812 |
| Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Day 3 (n = 27, 41) |
|
| Day 4 (n = 24, 27) |
|
| Day 5 (n = 12, 13) |
|
| Day 6 (n = 3, 5) |
|
| Day 7 (n = 1, 3) |
|
| 0.6751 |
| Superiority or Other |
| Comparison between groups for day 3. | Unequal Variance T-Test | 0.1203 | Superiority or Other |
| Comparison between groups for day 4. | Unequal Variance T-Test | 0.3582 | Superiority or Other |
| Comparison between groups for day 5 | Unequal Variance T-Test | 0.0625 | Superiority or Other |
| Comparison between groups for day 6. | Unequal Variance T-Test | 0.0484 | Superiority or Other |
| Day 3 (n = 27, 41) |
|
| Day 4 (n = 24, 27) |
|
| Day 5 (n = 12, 13) |
|
| Day 6 (n = 3, 5) |
|
| Day 7 (n=1, 3) |
|
| 0.9233 |
| Superiority or Other |
| Comparison between groups for day 3. | Unequal Variance T-Test | 0.5788 | Superiority or Other |
| Comparison between the groups for day 4. | Unequal Variance T-Test | 0.1036 | Superiority or Other |
| Comparison between groups for day 5. | Unequal Variance T-Test | 0.5314 | Superiority or Other |
| Comparison between groups for day 6. | Unequal Variance T-Test | 0.7166 | Superiority or Other |