Phase 4 N=20 Randomized Single-blind Treatment

Intercostal Nerve Cryoablation for Postoperative Pain Management

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT03972397 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Score on Numeric Pain Scale (NPS) — 1.5; 3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Intercostal Nerve Cryoablation (Device); Bupivacaine liposomal injectable suspension (Drug); Patient-controlled analgesia (PCA) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Score on Numeric Pain Scale (NPS)	1.5; 3	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Severity Score	2; 4	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY Brief Pain Inventory (BPI) - Pain Interference Score	0; 0	—
PRIMARY 5-point Satisfaction Scale	5; 5	—
PRIMARY 5-point Satisfaction Scale	5; 5	—
PRIMARY 5-point Satisfaction Scale	5; 5	—
PRIMARY 5-point Satisfaction Scale	5; 5	—
PRIMARY 5-point Satisfaction Scale	5; 5	—
SECONDARY Total Amount in mg of Opioid Medication Consumed	—	—
SECONDARY Number of Participants Who Require of Opioids at the Time of Discharge	—	—
SECONDARY Number of Participants Who Utilize Patient-controlled Analgesia (PCA)	—	—
SECONDARY Amount of Patient-controlled Analgesia (PCA) Used	—	—
SECONDARY Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours	—	—
SECONDARY Length of Hospital Stay	10.5; 8	—
SECONDARY Hospital Cost for Patient Care During Hospitalization	—	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT03972397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.