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N/A N=83 Randomized Treatment

Continuous Subpleural Infusion of Bupivacaine

Postoperative Pain

Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Number of Participants With and Without 30-Day Pain Medication Usage — 8; 6; 30; 36 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Subpleural pain catheter with infusion of 0.125% bupivacaine (Drug); Standard acute pain management (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Inova Health Care Services
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With and Without 30-Day Pain Medication Usage
8; 6; 30; 36
SECONDARY
7-day Paresthesia
3; 1; 25; 25; 10; 16
SECONDARY
Length of Stay
1; 1
SECONDARY
30-day Incidence of Parasthesia
13; 15; 25; 27
SECONDARY
Return to Work
18; 20; 3; 3; 17; 19
SECONDARY
Resumed Physical Activity
37; 37; 1; 5

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.

Eligibility 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01566838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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