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The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intercostal Nerve Cryoablation plus SOC Pain Control | Experimental | Standard of Care (SOC) |
|
| Standard of Care (SOC) Pain Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercostal Nerve Cryoablation | Device | Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Numeric Pain Scale (NPS) | The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain. | post-operative day 5 |
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | baseline |
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 3 |
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 4 |
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount in mg of Opioid Medication Consumed | third to fifth post-operative days after surgery | |
| Number of Participants Who Require of Opioids at the Time of Discharge | at the time of discharge (about a week after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony L Estrera, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intercostal Nerve Cryoablation Plus SOC Pain Control | Standard of Care (SOC) Intercostal Nerve Cryoablation: Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure. Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
| FG001 | Standard of Care (SOC) Pain Control | Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intercostal Nerve Cryoablation Plus SOC Pain Control | Standard of Care (SOC) Intercostal Nerve Cryoablation: Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure. Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Score on Numeric Pain Scale (NPS) | The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain. | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 5 |
|
At time of hospital discharge (about a week after surgery)
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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 | Intercostal Nerve Cryoablation Plus SOC Pain Control | Standard of Care (SOC) Intercostal Nerve Cryoablation: Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure. Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony L Estrera, MD | The University of Texas Health Science Center at Houston | 713-486-5100 | anthony.l.estrera@uth.tmc.edu |
Not provided
| 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 | Jun 5, 2019 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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|
|
| Bupivacaine liposomal injectable suspension | Drug | Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). |
|
|
| Patient-controlled analgesia (PCA) | Drug | Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
|
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 30 |
| Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | post-operative day 180 |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | baseline |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 3 |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 4 |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 5 |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 30 |
| Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | post-operative day 180 |
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | post-operative day 3 |
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | post-operative day 4 |
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | post-operative day 5 |
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | post-operative day 30 |
| 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | post-operative day 180 |
| Number of Participants Who Utilize Patient-controlled Analgesia (PCA) | from the time immediately after surgery to post-operative day 3 |
| Amount of Patient-controlled Analgesia (PCA) Used | from the time immediately after surgery to post-operative day 3 |
| Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours | 72 hours after surgery |
| Length of Hospital Stay | at the time of discharge (about a week after surgery) |
| Hospital Cost for Patient Care During Hospitalization | at the time of discharge (about a week after surgery) |
| BG001 | Standard of Care (SOC) Pain Control | Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care (SOC) Pain Control | Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. |
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | baseline |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 2 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 3 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 4 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 5 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 1 participant in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 30 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Severity Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. | Data were not collected for 1 participant in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 180 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | baseline |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 2 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 3 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 5 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 2 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 4 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 5 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 4 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 5 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 4 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 6 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 30 |
|
|
|
| Primary | Brief Pain Inventory (BPI) - Pain Interference Score | The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference. | Data were not collected for 3 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 3 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 180 |
|
|
|
| Primary | 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 2 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 3 |
|
|
|
| Primary | 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 4 |
|
|
|
| Primary | 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | Data were not collected for 2 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 5 |
|
|
|
| Primary | 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | Data were not collected for 4 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 6 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 30 |
|
|
|
| Primary | 5-point Satisfaction Scale | The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied". | Data were not collected for 3 participants in the Intercostal Nerve Cryoablation plus SOC Pain Control arm. Data were not collected for 3 participants in the Standard of Care (SOC) Pain Control arm. | Posted | Median | Inter-Quartile Range | score on a scale | post-operative day 180 |
|
|
|
| Secondary | Total Amount in mg of Opioid Medication Consumed | Data were not collected for this outcome measure. | Posted | third to fifth post-operative days after surgery |
|
|
| Secondary | Number of Participants Who Require of Opioids at the Time of Discharge | Data were not collected for this outcome measure. | Posted | at the time of discharge (about a week after surgery) |
|
|
| Secondary | Number of Participants Who Utilize Patient-controlled Analgesia (PCA) | Data were not collected for this outcome measure. | Posted | from the time immediately after surgery to post-operative day 3 |
|
|
| Secondary | Amount of Patient-controlled Analgesia (PCA) Used | Data were not collected for this outcome measure. | Posted | from the time immediately after surgery to post-operative day 3 |
|
|
| Secondary | Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours | Data were not collected for this outcome measure. | Posted | 72 hours after surgery |
|
|
| Secondary | Length of Hospital Stay | Posted | Median | Inter-Quartile Range | days | at the time of discharge (about a week after surgery) |
|
|
|
| Secondary | Hospital Cost for Patient Care During Hospitalization | Data were not collected for this outcome measure. | Posted | at the time of discharge (about a week after surgery) |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Standard of Care (SOC) Pain Control | Bupivacaine liposomal injectable suspension: Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml). Patient-controlled analgesia (PCA): Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. | 2 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |