NCT03972397 is a Phase 4 clinical trial of Intercostal Nerve Cryoablation in Pain, Postoperative, sponsored by The University of Texas Health Science Center, Houston.

Who is sponsoring NCT03972397?

NCT03972397 is sponsored by The University of Texas Health Science Center, Houston.

What drugs are being tested in NCT03972397?

Interventions in NCT03972397: Intercostal Nerve Cryoablation, Bupivacaine liposomal injectable suspension, Patient-controlled analgesia (PCA).

What condition does NCT03972397 study?

NCT03972397 studies Pain, Postoperative.

Is NCT03972397 still recruiting?

NCT03972397 is currently completed. Last updated 2 November 2023.

Are results published for NCT03972397?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-02 · How we verify

NCT03972397

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intercostal Nerve Cryoablation for Postoperative Pain Management

Completed Phase 4 Results posted Last updated 2 November 2023

What this trial tests

Phase 4 trial testing Intercostal Nerve Cryoablation in Pain, Postoperative in 20 participants. Completed in 22 September 2022.

Timeline

15 July 2019

Primary endpoint
22 September 2022

22 September 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	15 July 2019
Primary completion	22 September 2022
Estimated completion	22 September 2022
Sites	1 location across United States

Drugs / interventions tested

Intercostal Nerve Cryoablation
Bupivacaine liposomal injectable suspension — full drug profile →
Patient-controlled analgesia (PCA)

Conditions studied

Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Score on Numeric Pain Scale (NPS) Primary · 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.

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	1.5	0 – 3.25
Standard of Care (SOC) Pain Control	3	1 – 4

Brief Pain Inventory (BPI) - Severity Score Primary · baseline

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	3	0 – 8
Standard of Care (SOC) Pain Control	6	0 – 6

Brief Pain Inventory (BPI) - Severity Score Primary · post-operative day 3

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	5	.25 – 10
Standard of Care (SOC) Pain Control	6	3 – 7.75

Brief Pain Inventory (BPI) - Severity Score Primary · post-operative day 4

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	4.25	.25 – 7.5
Standard of Care (SOC) Pain Control	7	6 – 8

Brief Pain Inventory (BPI) - Severity Score Primary · post-operative day 5

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	4.75	1 – 8
Standard of Care (SOC) Pain Control	7	3 – 8

Brief Pain Inventory (BPI) - Severity Score Primary · post-operative day 30

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	5	2 – 7
Standard of Care (SOC) Pain Control	7	2 – 8

Brief Pain Inventory (BPI) - Severity Score Primary · post-operative day 180

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	2	0 – 5
Standard of Care (SOC) Pain Control	4	2 – 8

Brief Pain Inventory (BPI) - Pain Interference Score Primary · 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.

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	2.3	0 – 6
Standard of Care (SOC) Pain Control	0.1	0 – 4

Brief Pain Inventory (BPI) - Pain Interference Score Primary · post-operative day 3

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	1.8	0 – 5.1
Standard of Care (SOC) Pain Control	3.2	.1 – 4.5

Brief Pain Inventory (BPI) - Pain Interference Score Primary · post-operative day 4

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	1.1	.1 – 4.3
Standard of Care (SOC) Pain Control	2.9	.2 – 5.2

Brief Pain Inventory (BPI) - Pain Interference Score Primary · post-operative day 5

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	.4	0 – .9
Standard of Care (SOC) Pain Control	4.6	1.4 – 6.3

Brief Pain Inventory (BPI) - Pain Interference Score Primary · post-operative day 30

Group	Value	95% CI
Intercostal Nerve Cryoablation Plus SOC Pain Control	2.4	.1 – 5.0
Standard of Care (SOC) Pain Control	0.1	0 – 1.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Intercostal Nerve Cryoablation

Trials testing the same drug.

NCT05144828 — Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection · Phase 4 · completed

Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

NCT07512141 — Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy · NA · recruiting
NCT07354581 — Erector Spinae Plane Block vs Quadro-Iliac Plane Block After Lumbar Instrumentation Surgery · NA · recruiting
NCT07239817 — PENG Block + LIA For Endoprosthesis Surgery With Anterior Approach · NA · recruiting
NCT06740214 — Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty · Phase 3 · recruiting
NCT07057557 — Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites · NA · recruiting

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03972397 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 2 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03972397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing