Pain, PostoperativePhase 4NCT03972397

Intercostal Nerve Cryoablation for Postoperative Pain Management

A Phase 4 study testing Intercostal Nerve Cryoablation and Bupivacaine liposomal injectable suspension in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Intercostal Nerve Cryoablation and Bupivacaine liposomal injectable suspension
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2019to 22 Sep 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Descending/thoracoabdominal incision is planned
There is reasonable expectation that the patient will be extubated within 48 hours after surgery

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Pain, Postoperative
Being tested: Intercostal Nerve Cryoablation, Bupivacaine liposomal injectable suspension, Patient-controlled analgesia (PCA)
Keywords: Cryoablation
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intercostal Nerve CryoablationDevice
Also called CryoICE® CRYO2 cryoablation probes (AtriCure, Inc)
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 suspensionDrug
Also called Exparel® (Pacira Pharmacoceuticals)
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.

Study groups in NCT03972397
Study group	Role	What they receive
Intercostal Nerve Cryoablation plus SOC Pain Control	Experimental	Standard of Care (SOC) Receives: Device: Intercostal Nerve Cryoablation; Drug: Bupivacaine liposomal injectable suspension; Drug: Patient-controlled analgesia (PCA)
Standard of Care (SOC) Pain Control	Active comparator	Not described Receives: Drug: Bupivacaine liposomal injectable suspension; Drug: Patient-controlled analgesia (PCA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: post-operative day 180

Secondary outcomes (7)

Total Amount in mg of Opioid Medication Consumed
Measured: third to fifth post-operative days after surgery
Number of Participants Who Require of Opioids at the Time of Discharge
Measured: at the time of discharge (about a week after surgery)
Number of Participants Who Utilize Patient-controlled Analgesia (PCA)
Measured: from the time immediately after surgery to post-operative day 3
Amount of Patient-controlled Analgesia (PCA) Used
Measured: 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
Measured: 72 hours after surgery
Length of Hospital Stay
Measured: at the time of discharge (about a week after surgery)
Hospital Cost for Patient Care During Hospitalization
Measured: at the time of discharge (about a week after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201922 Sep 2022

First posted3 Jun 2019
Study start15 Jul 2019
Primary completion22 Sep 2022
Study completion22 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03972397
Sponsor's protocol ID: HSC-MS-19-0283
Status last verified: Oct 2023
First submitted: 30 May 2019
Last updated: 2 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
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Knee Arthroplasty, Total, Partial Knee Arthroplasty

All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intercostal Nerve Cryoablation for Postoperative Pain Management
ClinicalTrials.gov ID: NCT03972397
Acronym / sponsor ID: HSC-MS-19-0283
Conditions: Pain, Postoperative
Keywords: Cryoablation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 15 Jul 2019 (actual)
Primary completion: 22 Sep 2022 (actual)
Study completion: 22 Sep 2022 (actual)
First posted: 3 Jun 2019 (actual)
Results: Posted 2 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intercostal Nerve Cryoablation plus SOC Pain Control	Experimental	Device: Intercostal Nerve Cryoablation, Drug: Bupivacaine liposomal injectable suspension, Drug: Patient-controlled analgesia (PCA)Standard of Care (SOC)
Standard of Care (SOC) Pain Control	Active comparator	Drug: Bupivacaine liposomal injectable suspension, Drug: Patient-controlled analgesia (PCA)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Descending/thoracoabdominal incision is planned
There is reasonable expectation that the patient will be extubated within 48 hours after surgery

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intercostal Nerve CryoablationAlso: CryoICE® CRYO2 cryoablation probes (AtriCure, Inc)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.	Device	Intercostal Nerve Cryoablation plus SOC Pain Control
Bupivacaine liposomal injectable suspensionAlso: Exparel® (Pacira Pharmacoceuticals)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).	Drug	Intercostal Nerve Cryoablation plus SOC Pain Control, Standard of Care (SOC) Pain Control
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.	Drug	Intercostal Nerve Cryoablation plus SOC Pain Control, Standard of Care (SOC) Pain Control

Primary outcome

Score on Numeric Pain Scale (NPS)
Time frame: 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
Time frame: 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) - Severity Score
Time frame: post-operative day 3
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) - Severity Score
Time frame: post-operative day 4
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) - Severity Score
Time frame: post-operative day 5
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) - Severity Score
Time frame: post-operative day 30
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) - Severity Score
Time frame: post-operative day 180
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
Time frame: 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.
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: post-operative day 3
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.
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: post-operative day 4
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.
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: post-operative day 5
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.
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: post-operative day 30
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.
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: post-operative day 180
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
Time frame: 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".
5-point Satisfaction Scale
Time frame: post-operative day 4
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".
5-point Satisfaction Scale
Time frame: post-operative day 5
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".
5-point Satisfaction Scale
Time frame: post-operative day 30
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".
5-point Satisfaction Scale
Time frame: post-operative day 180
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".

7 secondary outcomes

Total Amount in mg of Opioid Medication Consumed
Time frame: third to fifth post-operative days after surgery
Number of Participants Who Require of Opioids at the Time of Discharge
Time frame: at the time of discharge (about a week after surgery)
Number of Participants Who Utilize Patient-controlled Analgesia (PCA)
Time frame: from the time immediately after surgery to post-operative day 3
Amount of Patient-controlled Analgesia (PCA) Used
Time frame: 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
Time frame: 72 hours after surgery
Length of Hospital Stay
Time frame: at the time of discharge (about a week after surgery)
Hospital Cost for Patient Care During Hospitalization
Time frame: at the time of discharge (about a week after surgery)

Results and safety

Results posted to the registry on 2 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intercostal Nerve Cryoablation Plus SOC Pain Control	10	10
Standard of Care (SOC) Pain Control	10	10

Primary outcome: Score on Numeric Pain Scale (NPS)

Time frame: post-operative day 5. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intercostal Nerve Cryoablation Plus SOC Pain Control n = 8	Standard of Care (SOC) Pain Control n = 9
Value	1.5 (0 to 3.25)	3 (1 to 4)

Population analysed: 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.

Primary outcome: Brief Pain Inventory (BPI) - Severity Score

Time frame: baseline. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intercostal Nerve Cryoablation Plus SOC Pain Control n = 10	Standard of Care (SOC) Pain Control n = 9
Value	3 (0 to 8)	6 (0 to 6)

Population analysed: Data were not collected for 1 participant in the Standard of Care (SOC) Pain Control arm.

Primary outcome: Brief Pain Inventory (BPI) - Severity Score

Time frame: post-operative day 3. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intercostal Nerve Cryoablation Plus SOC Pain Control n = 8	Standard of Care (SOC) Pain Control n = 8
Value	5 (.25 to 10)	6 (3 to 7.75)

Population analysed: 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.

Primary outcome: Brief Pain Inventory (BPI) - Severity Score

Time frame: post-operative day 4. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intercostal Nerve Cryoablation Plus SOC Pain Control n = 8	Standard of Care (SOC) Pain Control n = 9
Value	4.25 (.25 to 7.5)	7 (6 to 8)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: At time of hospital discharge (about a week after surgery). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intercostal Nerve Cryoablation Plus SOC Pain Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Standard of Care (SOC) Pain Control	0 of 10 (0%)	0 of 10 (0%)	2 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony L Estrera, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on Numeric Pain Scale (NPS) (time frame: post-operative day 5). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.