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Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01703351
Enrollment
79
Registered
2012-10-10
Start date
2012-10-04
Completion date
2015-11-06
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms, Postoperative Pain

Keywords

pain control, VATS

Brief summary

Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar, torque at trocar and working window by operator, and compression of intercostal nerves have been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous patient-controlled analgesia (IV PCA) that usually have used to control the operative pain, sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might reduce the side effects of IV PCA and control the operative pain effectively. In this study, we investigate the effectiveness of continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.

Interventions

(n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA)

DRUGFentanyl 500mcg + acupan 160mg + nasea 0.6mg

(n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No

Inclusion criteria

* Age; 18≥, \<75 * Thoracoscopic lobectomy due to lung cancer or suspected lung cancer * Tolerable cardiopulmonary and other systemic function tolerable to lobectomy * Karnofsky performance status ≥ 80 * Agree with study

Exclusion criteria

* Intolerable to one-lung ventilation * Bleeding risk due to Aspirin, coumadin and other drugs * Past or current history of depression or other psychiatric disease * Pain persisted before operation due to lung lesion * History of rib fracture, trauma or lung surgery at the same side of operation * Severe pleural adhesion or empyema * Open thoracotomy conversion * Reoperation due to postoperative bleeding or others * Postoperative complications that need ICU care * Chemical pleurodesis more than two times after operation * Do not agree with study

Design outcomes

Primary

MeasureTime frame
1. Acute painPain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)

Secondary

MeasureTime frame
2. Quality of lifemeasured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation

Other

MeasureTime frame
3. Neuropathic painVAS score and dose of analgesics in 4, 12 weeks after operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026