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

Pain Clinical Trial

— VATS_IM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00639795
• Other study ID #: A-13101.2 MMC 06-28
• Secondary ID: Proposal Log Num
• Status: Terminated
• Phase: N/A
• First received: March 14, 2008
• Last updated: July 2, 2013
• Start date: March 2008
• Est. completion date: March 2011

Study information

• Verified date: July 2013
• Source: Memorial Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Thoracic Paravertebral Nerve Block
One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia
• Thoracic Paravertebral Nerve Block
Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia

Locations

Country	Name	City	State
United States	Memorial Medical Center	Johnstown	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Medical Center	Henry M. Jackson Foundation for the Advancement of Military Medicine, U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain		1 year	No
Secondary	To compare the degree of pain and nausea		1 year	No