Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Memorial Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to compare:
- The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
- The degree of pain and nausea and
- 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.
Investigators
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:
- •patient refusal
- •active infection at site of planned block
- •documented allergy to any local or general anesthetic medications
Outcomes
Primary Outcomes
Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
Time Frame: 1 year
Secondary Outcomes
- To compare the degree of pain and nausea(1 year)