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

NCT ID: NCT00639795

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

A

Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure

Group Type: ACTIVE_COMPARATOR

Thoracic Paravertebral Nerve Block

Intervention Type: PROCEDURE

One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia

B

Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia

Group Type: SHAM_COMPARATOR

Thoracic Paravertebral Nerve Block

Intervention Type: PROCEDURE

Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia

Interventions

Thoracic Paravertebral Nerve Block

One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia

Intervention Type: PROCEDURE

Thoracic Paravertebral Nerve Block

Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia

Intervention Type: PROCEDURE

Other Intervention Names

VATS IM; Thoracic Peripheral Nerve Blockade

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Memorial Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Laurel Anesthesia Group, Memorial Medical Center

Principal Investigators

William T Fritz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Medical Center

Locations

Memorial Medical Center

Johnstown, Pennsylvania, United States

Countries

United States

Other Identifiers

Proposal Log Number 04070001

Identifier Type: -

Identifier Source: secondary_id

Award Number W81XWH-05-1-0047

Identifier Type: -

Identifier Source: secondary_id

A-13101.2 MMC 06-28

Identifier Type: -

Identifier Source: org_study_id