Clinical trial NCT01703351: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Postoperative Pain
Keywords: pain control, VATS
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 1. Acute pain
timeFrame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
Secondary outcomes:
measure: 2. Quality of life
timeFrame: measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation
Other outcomes:
measure: 3. Neuropathic pain
timeFrame: VAS score and dose of analgesics in 4, 12 weeks after operation
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
Study officials:
References: