Intercostal Nerve Block in Thoracoscopic Surgery Trial

JRCT ID: jRCT1031240358

Registered date:29/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases for which therapeutic thoracoscopic partial lung resection is indicated
• Date of first enrollment: 29/09/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients undergoing thoracoscopic surgery will be randomly assigned to two groups: one receiving intercostal nerve block at the beginning of the surgery, and the other receiving it before wound closure. The medication and dosage used for the intercostal nerve block will be identical in both groups.

Outcome(s)

• Primary Outcome: The primary endpoint is the Numerical Rating Scale (NRS) during movement 4 hours after returning to the room. The NRS ranges from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcome

the presence or absence of additional analgesics from the time of returning to the room until the primary outcome measurement
Intraoperative evaluation items: Intraoperative narcotic (remifentanil) usage, time from the end of surgery to extubation, presence of shivering, nausea, and use of antiemetics after extubation, highest blood pressure, maximum blood pressure change, maximum heart rate
Acute pain assessment during hospitalization: NRS at rest and during movement on POD0 (upon return to the room, 12 hours (just before the second Acetaminophen administration)), and on POD1-4 (during vital signs measurement)
Usage of analgesics
Quality of life (QOL) assessment: QOL assessment using the EQ5D and the SF-36 scale before surgery and at 3 months postoperatively, and evaluation of chronic pain (NRS at 3 months follow-up or by mail)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients scheduled for thoracoscopic partial lung resection using only a port (surgical approach without the assumption of using a utility window)
Age: 16 years or older and younger than 80 years at the time of consent acquisition
ASA-PS: 1-3
Patients who have received sufficient explanation regarding participation in this study, have fully understood it, and have provided written consent of their own free will

Exclude criteria

Patients for whom pain evaluation is difficult (e.g., due to dementia, agitation, mental illness, etc.)
Patients undergoing reoperation on the same side
Patients scheduled for bilateral surgery
Patients with renal dysfunction (as indicated by creatinine (Cre): male>1.07, female>0.79)
Patients with liver dysfunction (AST or ALT = or more 100)
Patients with an allergy to local anesthetics
Cases deemed unsuitable by the attending physician

Related Information

• Primary Sponsor: Ichimura Hideo
• Source(s) of Monetary Support: University of Tsukuba Hospital