Continuous Subpleural Infusion of Bupivacaine
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.
Timeline
- Start
- 2012-10
- Primary completion
- 2015-12
- Completion
- 2015-12
Publications
- Background Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
- Background Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
- Background Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
- Background Gurvich EB, Gladkova EV. [The results and outlook of a clinico-epidemiological study of the problem of the carcinogenic hazard in industry]. Gig Tr Prof Zabol. 1992;(7):17-20. Russian.
- Background Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
- Background American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.125 % | Other |
| Comparator | Acetaminophen | Small molecule | 1000 mg | Oral |
| Comparator | Etomidate | Small molecule | — | — |
| Comparator | Fentanyl | Other / unclassified | — | — |
| Comparator | Ketorolac | Other / unclassified | 30 mg | Intravenous |
| Comparator | Midazolam | Small molecule | — | — |
| Comparator | Ondansetron | Other / unclassified | 4 mg | — |
| Comparator | Propofol | Small molecule | — | — |
| Comparator | Rocuronium | Other / unclassified | 0.1 mg/kg | — |
| Comparator | Sevoflurane | Other / unclassified | — | — |
Indications
No indication recorded.