Pain, Postoperative
Conditions
Keywords
Cryoablation
Brief summary
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.
Interventions
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.
DRUGBupivacaine 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).
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Descending/thoracoabdominal incision is planned * There is reasonable expectation that the patient will be extubated within 48 hours after surgery
Exclusion criteria
* The patient has a known allergy to morphine or any opioid * The patient has a known chronic pain disorder or takes daily opioid medication \> 1 month prior to surgery * The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 48 hours after surgery There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Numeric Pain Scale (NPS) | post-operative day 5 | 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. |
| Brief Pain Inventory (BPI) - Severity Score | baseline | 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. |
| Brief Pain Inventory (BPI) - Pain Interference Score | baseline | 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. |
| 5-point Satisfaction Scale | post-operative day 3 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours | 72 hours after surgery |
| Total Amount in mg of Opioid Medication Consumed | third to fifth post-operative days after surgery |
| Hospital Cost for Patient Care During Hospitalization | at the time of discharge (about a week after surgery) |
| Length of Hospital Stay | at the time of discharge (about a week after surgery) |
| Number of Participants Who Require of Opioids at the Time of Discharge | at the time of discharge (about a week after surgery) |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intercostal Nerve Cryoablation Plus SOC Pain Control | Standard of Care (SOC) Pain Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 55.3 years STANDARD_DEVIATION 9.63 | 54.4 years STANDARD_DEVIATION 14.75 | 54.85 years STANDARD_DEVIATION 13.2 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 2 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: post-operative day 30
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | 5-point Satisfaction Scale | 5 score on a scale |
| Standard of Care (SOC) Pain Control | 5-point Satisfaction Scale | 4.5 score on a scale |
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.
Time frame: post-operative day 5
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | 5-point Satisfaction Scale | 4.5 score on a scale |
| Standard of Care (SOC) Pain Control | 5-point Satisfaction Scale | 4 score on a scale |
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.
Time frame: post-operative day 3
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | 5-point Satisfaction Scale | 5 score on a scale |
| Standard of Care (SOC) Pain Control | 5-point Satisfaction Scale | 3.5 score on a scale |
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.
Time frame: post-operative day 4
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | 5-point Satisfaction Scale | 5 score on a scale |
| Standard of Care (SOC) Pain Control | 5-point Satisfaction Scale | 3 score on a scale |
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.
Time frame: post-operative day 180
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | 5-point Satisfaction Scale | 5 score on a scale |
| Standard of Care (SOC) Pain Control | 5-point Satisfaction Scale | 5 score on a scale |
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.
Time frame: baseline
Population: Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 2.3 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 0.1 score on a scale |
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.
Time frame: post-operative day 180
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 0 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 0 score on a scale |
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.
Time frame: post-operative day 3
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 1.8 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 3.2 score on a scale |
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.
Time frame: post-operative day 4
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 1.1 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 2.9 score on a scale |
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.
Time frame: post-operative day 5
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | .4 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 4.6 score on a scale |
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.
Time frame: post-operative day 30
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 2.4 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Pain Interference Score | 0.1 score on a scale |
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.
Time frame: post-operative day 180
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 2 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 4 score on a scale |
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.
Time frame: post-operative day 5
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 4.75 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 7 score on a scale |
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.
Time frame: post-operative day 30
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 5 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 7 score on a scale |
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.
Time frame: post-operative day 4
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 4.25 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 7 score on a scale |
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.
Time frame: baseline
Population: Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 3 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 6 score on a scale |
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.
Time frame: post-operative day 3
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Brief Pain Inventory (BPI) - Severity Score | 5 score on a scale |
| Standard of Care (SOC) Pain Control | Brief Pain Inventory (BPI) - Severity Score | 6 score on a scale |
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.
Time frame: post-operative day 5
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Score on Numeric Pain Scale (NPS) | 1.5 score on a scale |
| Standard of Care (SOC) Pain Control | Score on Numeric Pain Scale (NPS) | 3 score on a scale |
Secondary
Amount of Patient-controlled Analgesia (PCA) Used
Time frame: from the time immediately after surgery to post-operative day 3
Population: Data were not collected for this outcome measure.
Secondary
Hospital Cost for Patient Care During Hospitalization
Time frame: at the time of discharge (about a week after surgery)
Population: Data were not collected for this outcome measure.
Secondary
Length of Hospital Stay
Time frame: at the time of discharge (about a week after surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intercostal Nerve Cryoablation Plus SOC Pain Control | Length of Hospital Stay | 10.5 days |
| Standard of Care (SOC) Pain Control | Length of Hospital Stay | 8 days |
Secondary
Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours
Time frame: 72 hours after surgery
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants Who Require of Opioids at the Time of Discharge
Time frame: at the time of discharge (about a week after surgery)
Population: Data were not collected for this outcome measure.
Secondary
Number of Participants Who Utilize Patient-controlled Analgesia (PCA)
Time frame: from the time immediately after surgery to post-operative day 3
Population: Data were not collected for this outcome measure.
Secondary
Total Amount in mg of Opioid Medication Consumed
Time frame: third to fifth post-operative days after surgery
Population: Data were not collected for this outcome measure.