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

NCT00639795 | Terminated DMC

• 3 other identifiers: A-13101.2 MMC 06-28Proposal Log Number 04070001Award Number W81XWH-05-1-0047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare:

1. 1.The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
2. 2.The degree of pain and nausea and
3. 3.The pre and post operative pulmonary functions

Conditions

Pain

Keywords

Thoracic paravertebral block; Cytokines; Video assisted thorascopic surgery; Pain

Outcome Measures

Primary Outcomes (1)

• Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain

  1 year

Secondary Outcomes (1)

• To compare the degree of pain and nausea

  1 year

Study Arms (2)

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

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

Interventions

Thoracic Paravertebral Nerve Block PROCEDURE

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

Also known as: VATS IM, Thoracic Peripheral Nerve Blockade

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18
• Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure

You may not qualify if:

• 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
• significant coagulopathy( prothrombin time \>15 seconds, INR\>1.5
• 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)

Sponsors & Collaborators

• Memorial Medical Center: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Memorial Medical Center

Johnstown, Pennsylvania, 15905, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William T Fritz, MD

  Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

US (1)