Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery (VATS_IM)

This study has been terminated.
(inadequate sample population)
Sponsor:
Collaborators:
Henry M Jackson Foundation
U.S. Army Medical Research and Materiel Command
Information provided by:
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00639795
First received: March 14, 2008
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Pain
Procedure: Thoracic Paravertebral Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
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:


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
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
Other Names:
  • VATS IM
  • Thoracic Peripheral Nerve Blockade
Sham Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Memorial Medical Center
Johnstown, Pennsylvania, United States, 15905
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: William T Fritz, M.D., Laurel Anesthesia Group, Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00639795     History of Changes
Other 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: July 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Medical Center:
Thoracic paravertebral block
Cytokines
Video assisted thorascopic surgery
Pain

ClinicalTrials.gov processed this record on July 29, 2014