Continuous Subpleural Infusion of Bupivacaine

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del

Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval.

Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay.

The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications.

Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay.

Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology:

Total amount of narcotic pain medication administered through postoperative day 7, will be compared between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inova Health Care Services
• Treatments: Bupivacaine; Fentanyl

Criteria

Inclusion Criteria:

• All patients over 18 years of age

• Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion Criteria:

• Previous ipsilateral thoracic surgery

• Need for operative pleurectomy or pleurodesis

• Chronic use of pain medication (narcotics or NSAIDS), sedatives or hypnotics

• Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen

• Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)

• Renal dysfunction (eGFR < 60ml/min/1.73m2)

• History of peptic ulcerative disease

• Sleep apnea in need of Bipap

• Severe COPD requiring continuous oxygen supplementation

• Inability to consent

• Pregnancy