Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery - Full Text View

Sponsors and Collaborators:	Memorial Medical Center Henry M Jackson Foundation U.S. Army Medical Research and Materiel Command
Information provided by:	Memorial Medical Center
ClinicalTrials.gov Identifier:	NCT00639795

Purpose

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

Condition	Intervention
Pain	Procedure: Thoracic Paravertebral Nerve Block

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Nausea and Vomiting Surgery

U.S. FDA Resources

Further study details as provided by Memorial Medical Center:

Primary Outcome Measures:

Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the degree of pain and nausea [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure	Procedure: Thoracic Paravertebral Nerve Block One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia
B: Sham Comparator Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia	Procedure: Thoracic Paravertebral Nerve Block Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639795

Contacts

Contact: Jean Garguilo, BS	814-534-1447	jgargui@conemaugh.org
Contact: Kim Edwards, RN	814-534-3452	kedwards@conemaugh.org

Locations

United States, Pennsylvania
Memorial Medical Center	Recruiting
Johnstown, Pennsylvania, United States, 15905
Principal Investigator: William T Fritz, MD

Sponsors and Collaborators

Memorial Medical Center

Henry M Jackson Foundation

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

William T Fritz, MD

Memorial Medical Center

More Information

No publications provided

Responsible Party:	Laurel Anesthesia Group, Memorial Medical Center ( William T Fritz, M.D. )
Study ID Numbers:	A-13101.2 MMC 06-28, Proposal Log Number 04070001, Award Number W81XWH-05-1-0047
Study First Received:	March 14, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00639795 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Medical Center:

Thoracic paravertebral block
Cytokines
Video assisted thorascopic surgery
Pain

Study placed in the following topic categories:

Anesthetics
Pain
Pain, Postoperative
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009