Pectus Excavatum
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEON-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. 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.
DRUGEpidural (ropivicaine 0.25%)
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.
Sponsors
Halyard Health
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for repair of their pectus excavatum with minimally invasive (MIRPE) placement of steel or titanium braces at Mayo Clinic Arizona * Must be able to take oral medications preoperatively and postoperatively.
Exclusion criteria
* American Society of Anesthesiology class IV or higher * Allergic to Ropivacaine or other local anesthetics * NSAID allergy * Specific epidural contraindication * Currently using opioids, sedatives, or hypnotics * Are pregnant as verified by preoperative pregnancy testing * Inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Up to 11 days post operation | Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11. |
| Use of Analgesic Narcotic | 1-7 days post operation | Postoperative analgesic used each day over 7 day postoperative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Pain Score | Days 1-7 post operation | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from Mayo Clinic in Phoenix, Arizona.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 41 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to tolerate catheter placement | 3 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 1 |
Baseline characteristics
| Characteristic | Thoracic Epidural | ON-Q Soaker Catheter System | Total |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 8.4 | 32.8 years STANDARD_DEVIATION 9.4 | 32.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 27 participants | 41 participants | 85 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 21 Participants | 31 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 30 | 11 / 55 |
| serious Total, serious adverse events | 0 / 30 | 0 / 55 |
Outcome results
Primary
Hospital Length of Stay
Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
Time frame: Up to 11 days post operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thoracic Epidural | Hospital Length of Stay | 3.5 days | Standard Deviation 0.9 |
| ON-Q Soaker Catheter System | Hospital Length of Stay | 3.3 days | Standard Deviation 1.6 |
p-value: 0.55t-test, 2 sided
Primary
Use of Analgesic Narcotic
Postoperative analgesic used each day over 7 day postoperative period.
Time frame: 1-7 days post operation
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Epidural | Use of Analgesic Narcotic | Day 4 (n = 24, 27) | 65.8 morphine milligram equivalents | Standard Deviation 46.1 |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 1 (n = 27, 41) | 40.8 morphine milligram equivalents | Standard Deviation 38.5 |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 5 (n = 12, 13) | 43.5 morphine milligram equivalents | Standard Deviation 33.4 |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 3 (n = 27, 41) | 79.7 morphine milligram equivalents | Standard Deviation 42.7 |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 6 (n = 3, 5) | 30.8 morphine milligram equivalents | Standard Deviation 27.4 |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 7 (n = 1, 3) | 24.0 morphine milligram equivalents | — |
| Thoracic Epidural | Use of Analgesic Narcotic | Day 2 (n = 27, 41) | 99.5 morphine milligram equivalents | Standard Deviation 71.1 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 7 (n = 1, 3) | 81.9 morphine milligram equivalents | Standard Deviation 19 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 1 (n = 27, 41) | 58.7 morphine milligram equivalents | Standard Deviation 45.8 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 2 (n = 27, 41) | 107.2 morphine milligram equivalents | Standard Deviation 76.1 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 3 (n = 27, 41) | 62.4 morphine milligram equivalents | Standard Deviation 46.9 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 4 (n = 24, 27) | 79.4 morphine milligram equivalents | Standard Deviation 57.8 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 5 (n = 12, 13) | 78.8 morphine milligram equivalents | Standard Deviation 54.2 |
| ON-Q Soaker Catheter System | Use of Analgesic Narcotic | Day 6 (n = 3, 5) | 86.4 morphine milligram equivalents | Standard Deviation 31.9 |
Comparison: Comparison between the groups for day 1.p-value: 0.0872Unequal Variance T-Test
Comparison: Comparison between groups for day 2.p-value: 0.6751Unequal Variance T-Test
Comparison: Comparison between groups for day 3.p-value: 0.1203Unequal Variance T-Test
Comparison: Comparison between groups for day 4.p-value: 0.3582Unequal Variance T-Test
Comparison: Comparison between groups for day 5p-value: 0.0625Unequal Variance T-Test
Comparison: Comparison between groups for day 6.p-value: 0.0484Unequal Variance T-Test
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.
Time frame: Days 1-7 post operation
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thoracic Epidural | Mean Daily Pain Score | Day 3 (n = 27, 41) | 3.16 units on a scale | Standard Deviation 1.31 |
| Thoracic Epidural | Mean Daily Pain Score | Day 5 (n = 12, 13) | 2.95 units on a scale | Standard Deviation 1.22 |
| Thoracic Epidural | Mean Daily Pain Score | Day 2 (n = 27, 41) | 2.64 units on a scale | Standard Deviation 1.41 |
| Thoracic Epidural | Mean Daily Pain Score | Day 6 (n = 3, 5) | 3.28 units on a scale | Standard Deviation 0.25 |
| Thoracic Epidural | Mean Daily Pain Score | Day 4 (n = 24, 27) | 3.03 units on a scale | Standard Deviation 1.25 |
| Thoracic Epidural | Mean Daily Pain Score | Day 7 (n=1, 3) | 4.50 units on a scale | — |
| Thoracic Epidural | Mean Daily Pain Score | Day 1 (n = 27, 41) | 2.19 units on a scale | Standard Deviation 1.76 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 7 (n=1, 3) | 4.13 units on a scale | Standard Deviation 1.65 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 1 (n = 27, 41) | 2.39 units on a scale | Standard Deviation 1.72 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 2 (n = 27, 41) | 2.60 units on a scale | Standard Deviation 1.4 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 3 (n = 27, 41) | 2.97 units on a scale | Standard Deviation 1.36 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 4 (n = 24, 27) | 3.60 units on a scale | Standard Deviation 1.19 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 5 (n = 12, 13) | 3.30 units on a scale | Standard Deviation 1.5 |
| ON-Q Soaker Catheter System | Mean Daily Pain Score | Day 6 (n = 3, 5) | 3.55 units on a scale | Standard Deviation 1.52 |
Comparison: Comparison between the groups for day 1.p-value: 0.6465Unequal Variance T-Test
Comparison: Comparison between groups for day 2.p-value: 0.9233Unequal Variance T-Test
Comparison: Comparison between groups for day 3.p-value: 0.5788Unequal Variance T-Test
Comparison: Comparison between the groups for day 4.p-value: 0.1036Unequal Variance T-Test
Comparison: Comparison between groups for day 5.p-value: 0.5314Unequal Variance T-Test
Comparison: Comparison between groups for day 6.p-value: 0.7166Unequal Variance T-Test