Trial Outcomes & Findings for Rib Fracture Analgesia Using Cryoanalgesia (NCT NCT04198662)
NCT ID: NCT04198662
Last Updated: 2024-10-10
Results Overview
maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Day 1 of study treatment
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 19 • n=11 Participants
|
57 years
STANDARD_DEVIATION 14 • n=9 Participants
|
52 years
STANDARD_DEVIATION 16 • n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
7 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
20 Participants
n=20 Participants
|
|
Weight
|
90 kg
STANDARD_DEVIATION 19 • n=11 Participants
|
83 kg
STANDARD_DEVIATION 22 • n=9 Participants
|
87 kg
STANDARD_DEVIATION 21 • n=20 Participants
|
|
Body mass index
|
27 kg/m^2
STANDARD_DEVIATION 7 • n=11 Participants
|
30 kg/m^2
STANDARD_DEVIATION 6 • n=9 Participants
|
28 kg/m^2
STANDARD_DEVIATION 7 • n=20 Participants
|
|
Fractured ribs (total)
|
4.1 number of ribs
STANDARD_DEVIATION 1.4 • n=11 Participants
|
3.9 number of ribs
STANDARD_DEVIATION 1.5 • n=9 Participants
|
4.0 number of ribs
STANDARD_DEVIATION 1.4 • n=20 Participants
|
|
Fractured ribs (left)
|
1.7 number of ribs
STANDARD_DEVIATION 1.8 • n=11 Participants
|
2.0 number of ribs
STANDARD_DEVIATION 2.5 • n=9 Participants
|
1.8 number of ribs
STANDARD_DEVIATION 2.1 • n=20 Participants
|
|
Fractured ribs (right)
|
2.4 number of ribs
STANDARD_DEVIATION 2.3 • n=11 Participants
|
1.9 number of ribs
STANDARD_DEVIATION 2.1 • n=9 Participants
|
2.1 number of ribs
STANDARD_DEVIATION 2.2 • n=20 Participants
|
|
Unilateral fracture(s)
|
9 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=20 Participants
|
|
Bilateral fracture(s)
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
Inspiratory volume at baseline
|
1222 mL
STANDARD_DEVIATION 551 • n=11 Participants
|
1023 mL
STANDARD_DEVIATION 564 • n=9 Participants
|
1127 mL
STANDARD_DEVIATION 557 • n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1 of study treatmentmaximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Maximum Inspired Volume
|
2250 mL
Interval 1500.0 to 2500.0
|
1300 mL
Interval 750.0 to 2500.0
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Maximum Inspired Volume
Prior to intervention (baseline)
|
1000 mL
Interval 625.0 to 1125.0
|
1000 mL
Interval 750.0 to 1500.0
|
|
Maximum Inspired Volume
Immediately following intervention
|
2000 mL
Interval 2000.0 to 2625.0
|
1750 mL
Interval 1000.0 to 2250.0
|
|
Maximum Inspired Volume
Day 1
|
2250 mL
Interval 1500.0 to 2500.0
|
1300 mL
Interval 750.0 to 2500.0
|
|
Maximum Inspired Volume
Day 2
|
2250 mL
Interval 1500.0 to 2500.0
|
1000 mL
Interval 500.0 to 2500.0
|
|
Maximum Inspired Volume
Day 7
|
2000 mL
Interval 1875.0 to 2275.0
|
1750 mL
Interval 1225.0 to 3000.0
|
|
Maximum Inspired Volume
Day 14
|
2250 mL
Interval 2000.0 to 2550.0
|
2000 mL
Interval 1500.0 to 2775.0
|
|
Maximum Inspired Volume
Month 1
|
2500 mL
Interval 2200.0 to 2750.0
|
2250 mL
Interval 1500.0 to 3125.0
|
|
Maximum Inspired Volume
Month 1.5
|
2500 mL
Interval 2250.0 to 3325.0
|
2700 mL
Interval 2500.0 to 3375.0
|
|
Maximum Inspired Volume
Month 2
|
3000 mL
Interval 2500.0 to 3300.0
|
3250 mL
Interval 2875.0 to 3625.0
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2Worst pain level during the same-day spirometry use as measured using the 11-point Numeric Rating Scale with 0= no pain and 10= worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Spirometry Pain
Month 1
|
0 score on a scale
Interval 0.0 to 2.8
|
6 score on a scale
Interval 3.0 to 9.0
|
|
Spirometry Pain
Prior to intervention (baseline)
|
10 score on a scale
Interval 7.0 to 10.0
|
10 score on a scale
Interval 7.0 to 10.0
|
|
Spirometry Pain
Immediately following intervention
|
3 score on a scale
Interval 0.0 to 5.0
|
5 score on a scale
Interval 2.0 to 6.0
|
|
Spirometry Pain
Day 1
|
2 score on a scale
Interval 0.0 to 7.0
|
8 score on a scale
Interval 5.0 to 10.0
|
|
Spirometry Pain
Day 2
|
3 score on a scale
Interval 1.5 to 7.0
|
7 score on a scale
Interval 3.0 to 10.0
|
|
Spirometry Pain
Day 7
|
2 score on a scale
Interval 0.8 to 4.8
|
7.5 score on a scale
Interval 2.3 to 10.0
|
|
Spirometry Pain
Day 14
|
1 score on a scale
Interval 0.0 to 4.0
|
4.5 score on a scale
Interval 2.8 to 6.3
|
|
Spirometry Pain
Month 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
3 score on a scale
Interval 1.0 to 9.0
|
|
Spirometry Pain
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
3.8 score on a scale
Interval 0.8 to 7.3
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7The Brief Pain Inventory (Pain Scale) measures pain intensities: (1) worst pain; (2) least pain; (3) average pain; and (4) current pain. Each of these is measured using a 0-10 numeric rating scale, in which 0 is equivalent to no pain and 10 the worst imaginable. Then, all 4 are added together to produce a scale with values ranging from 0-40, with 0 equivalent to no pain and 40 the maximum pain.
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Brief Pain Inventory (Pain Scale)
Day 1
|
7 score on a scale
Interval 5.0 to 12.0
|
28 score on a scale
Interval 13.0 to 29.0
|
|
Brief Pain Inventory (Pain Scale)
Day 2
|
7 score on a scale
Interval 6.0 to 12.0
|
21 score on a scale
Interval 14.0 to 31.0
|
|
Brief Pain Inventory (Pain Scale)
Day 7
|
6 score on a scale
Interval 3.0 to 11.0
|
26 score on a scale
Interval 16.0 to 31.0
|
SECONDARY outcome
Timeframe: Day 14, and Months 1, 1.5, 2, 3, 6, and 12The Brief Pain Inventory (Interference Scale) assesses pain's interference with physical and emotional functioning (time frame: previous 24 h). The instrument measures interference with physical and emotional functioning using a 0-10 scale (0 = no interference; 10 = complete interference). The seven interference questions involve general activity, mood, walking ability, normal work activities (both inside and outside of the home), relationships, sleep, and enjoyment of life. These seven responses are then combined to produce an interference scale (0-70), with 0 equivalent to no interference (good) and 70 equivalent to the maximum interference (bad).
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Brief Pain Inventory (Interference Scale)
Day 14
|
0 score on a scale
Interval 0.0 to 16.0
|
30 score on a scale
Interval 7.0 to 54.0
|
|
Brief Pain Inventory (Interference Scale)
Month 1
|
0 score on a scale
Interval 0.0 to 3.0
|
24 score on a scale
Interval 6.0 to 58.0
|
|
Brief Pain Inventory (Interference Scale)
Month 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
1 score on a scale
Interval 0.0 to 29.0
|
|
Brief Pain Inventory (Interference Scale)
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
4 score on a scale
Interval 0.0 to 11.0
|
|
Brief Pain Inventory (Interference Scale)
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Brief Pain Inventory (Interference Scale)
Month 6
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Brief Pain Inventory (Interference Scale)
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12Recorded as the number of awakenings subject-identified as due to pain during the previous evening
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Sleep Disturbances Due to Pain
Day 1
|
0 number of awakenings
Interval 0.0 to 1.0
|
2 number of awakenings
Interval 0.0 to 4.0
|
|
Sleep Disturbances Due to Pain
Day 2
|
0 number of awakenings
Interval 0.0 to 1.0
|
3 number of awakenings
Interval 1.0 to 5.0
|
|
Sleep Disturbances Due to Pain
Day 7
|
0 number of awakenings
Interval 0.0 to 1.0
|
4 number of awakenings
Interval 2.0 to 9.0
|
|
Sleep Disturbances Due to Pain
Day 14
|
0 number of awakenings
Interval 0.0 to 0.0
|
2 number of awakenings
Interval 1.0 to 4.0
|
|
Sleep Disturbances Due to Pain
Month 1
|
0 number of awakenings
Interval 0.0 to 0.0
|
1 number of awakenings
Interval 0.0 to 1.0
|
|
Sleep Disturbances Due to Pain
Month 1.5
|
0 number of awakenings
Interval 0.0 to 0.0
|
1 number of awakenings
Interval 0.0 to 1.0
|
|
Sleep Disturbances Due to Pain
Month 2
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 1.0
|
|
Sleep Disturbances Due to Pain
Month 3
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 1.0
|
|
Sleep Disturbances Due to Pain
Month 6
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.0
|
|
Sleep Disturbances Due to Pain
Month 12
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12Recorded as the amount of oral oxycodone-equivalent analgesics consumed in previous 24 hours (measured in mg)
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Oral Opioid Consumption
Day 1
|
0 mg
Interval 0.0 to 8.0
|
35 mg
Interval 21.0 to 55.0
|
|
Oral Opioid Consumption
Day 2
|
0 mg
Interval 0.0 to 5.0
|
18 mg
Interval 10.0 to 30.0
|
|
Oral Opioid Consumption
Day 7
|
0 mg
Interval 0.0 to 2.0
|
15 mg
Interval 10.0 to 23.0
|
|
Oral Opioid Consumption
Day 14
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 6.0
|
|
Oral Opioid Consumption
Month 1
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Oral Opioid Consumption
Month 1.5
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 1.0
|
|
Oral Opioid Consumption
Month 2
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Oral Opioid Consumption
Month 3
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Oral Opioid Consumption
Month 6
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
|
Oral Opioid Consumption
Month 12
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 7, 14Recorded as the amount of intravenous morphine-equivalent analgesics consumed in previous 24 hours (measured in mg)
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Intravenous Opioid Consumption
Day 1
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Intravenous Opioid Consumption
Day 2
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Intravenous Opioid Consumption
Day 7
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Intravenous Opioid Consumption
Day 14
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearThe number of days following the study procedure of primary discharge from the hospital
Outcome measures
| Measure |
Cryoneurolysis and Placebo Intercostal Nerve Block
n=11 Participants
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas): The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Placebo intercostal nerve block with normal saline: 3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks
|
Sham Cryoneurolysis and Active Intercostal Nerve Block
n=9 Participants
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Intercostal nerve block ropivacaine with epinephrine: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
Sham cryoneurolysis with a Painblocker: The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
|
|---|---|---|
|
Day of Discharge
|
0.7 days
Standard Deviation 1.0
|
1.4 days
Standard Deviation 1.2
|
Adverse Events
Cryoneurolysis and Placebo Intercostal Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Cryoneurolysis and Active Intercostal Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian M. Ilfeld, MD, MS
University of California, San Diego
Phone: (858) 822-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place