Clinical trial NCT00639795: Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery
Official title: Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Thoracic paravertebral block
Cytokines
Video assisted thorascopic surgery
Pain
Lead sponsor: Memorial Medical Center
Sponsor class: OTHER
Collaborators: name: Henry M. Jackson Foundation for the Advancement of Military Medicine
name: U.S. Army Medical Research and Development Command
First posted: 2008-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare:

1. The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
2. The degree of pain and nausea and
3. The pre and post operative pulmonary functions

following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade

Detailed description: * Enrolled subjects scheduled to undergo video-assisted thorascopic surgery (VATS) will be randomized to receive either paravertebral block or placebo(adhesive bandage applied at the site).
* All patients will undergo a standardized general anesthetic regimen.
* Human biological specimens will be collected preoperatively, postoperatively (in the PACU) at the first morning blood draw of POD 1, POD 2, POD 3, and POD 10-14 (follow-up visit at surgeons office)and analyzed for CRP, Cortisol \& inflammatory markers (IL-1beta,IL-2,IL-4,IL-5,IL-6, IL-8, IL-10,INF-gamma, TNF-alpha)
* Pulmonary functions (FEV1/FEV6) will be performed in the pre-op holding area prior to sedation and post-operatively on the morning of post-op day 1.
* Pain levels will be assessed with the Wong-Baker Faces and Visual Analog Scale pre-operatively in the PACU and hourly for a total of 6 hours and then every 8 hrs.and with patient self-report in diary after discharge.
* Pain levels will be assessed with the McGill-Melzack Pain Questionnaire pre-operatively, the evening of POD1-POD3 and by patient self-report in diary after discharge.
* Nausea assessments will occur at arrival on floor and every 8 hours thereafter until discharge.
* Narcotic requirements will be collected daily in the hospital and by patient self report in diary thereafter.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18
* Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure

Exclusion Criteria:

* Age less than 18
* Clinical or laboratory evidence of systemic infection
* Current pregnancy as assessed by preoperative urine HCG test
* Serious, uncontrolled, non-malignant illness
* Malignant illness requiring systemic chemotherapy in the last 6 months
* Documented allergy to oxycodone, morphine sulfate or acetaminophen
* Contraindication to peripheral nerve blockade or general anesthesia including:

  1. patient refusal
  2. active infection at site of planned block
  3. documented allergy to any local or general anesthetic medications
  4. significant coagulopathy( prothrombin time \>15 seconds, INR\>1.5
  5. pre-existing neuropathy and medical conditions or deformities which would compromise block or anesthetic safety
* Planned pleurodesis
* Current use of high dose inhaled or systemic steroids
* Current use of Amiodarone (Cordarone)
* Morbid obesity (BMI=40kg/m2)
* Patients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications.
* Patients unable to consent
* Patients with active infections requiring antibiotics within one month of registration
* Participation in other clinical trials that may interfere with this study

Primary outcomes:
measure: Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
timeFrame: 1 year
Secondary outcomes:
measure: To compare the degree of pain and nausea
timeFrame: 1 year
Other outcomes:
Locations:
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
Study officials:
affiliation: Memorial Medical Center
name: William T Fritz, MD
role: PRINCIPAL_INVESTIGATOR
References: