Intercostal Nerve Cryoablation for Postoperative Pain Management

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Device: Intercostal Nerve Cryoablation; Drug: Bupivacaine liposomal injectable suspension; Drug: Patient-controlled analgesia (PCA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03972397

HSC-MS-19-0283

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Intercostal Nerve Cryoablation plus SOC Pain Control

Experimental group

Description:

Standard of Care (SOC)

Treatment:

Drug: Patient-controlled analgesia (PCA)

Drug: Bupivacaine liposomal injectable suspension

Device: Intercostal Nerve Cryoablation

Standard of Care (SOC) Pain Control

Active Comparator group

Treatment:

Drug: Patient-controlled analgesia (PCA)

Drug: Bupivacaine liposomal injectable suspension