Continuous Subpleural Infusion of Bupivacaine

NCT01566838 | Completed Results

• 1 other identifier: 120104onq
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Visual analog pain score; Length of stay; Hospital Cost; Subpleural pain catheter; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With and Without 30-Day Pain Medication Usage

  The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.

  Postoperative day 1 through postoperative day 30

Secondary Outcomes (5)

• 7-day Paresthesia

  Postoperative day 1 through day 7

• Length of Stay

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

• 30-day Incidence of Parasthesia

  30 days

• Return to Work

  30 days

• Resumed Physical Activity

  30 days

Study Arms (2)

On-q pump

ACTIVE COMPARATOR

Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.

Drug: Subpleural pain catheter with infusion of 0.125% bupivacaine

Standard of care

ACTIVE COMPARATOR

Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will also be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation. The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.

Drug: Standard acute pain management

Interventions

Subpleural pain catheter with infusion of 0.125% bupivacaine DRUG

Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.

Also known as: On-q pump

On-q pump

Standard acute pain management DRUG

A standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV, neuromuscular reversal agents, and ondansetron 4mg. Fentanyl will be given, as needed, to facilitate patient comfort and extubation. The ASA guidelines for acute pain management in the perioperative period will be followed. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.

Standard of care

Eligibility Criteria

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

You may qualify if:

• All patients over 18 years of age
• Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (6)

• 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.

  PMID: 19022040 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.

  PMID: 19699918 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.

  PMID: 1914056 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.

  PMID: 1296910 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.

  PMID: 9725371 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.

  PMID: 15166580 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

This study limited by a low power and reliance on patient self-reporting.

Results Point of Contact

• Title: Sandeep Khandhar, MD
• Organization: Cardiac, Vascular, and Thoracic Surgery Associates

SKhandhar@CVTSA.com

703-280-5858

Study Officials

• Daniel L Fortes, MD

  Cardiac, Vascular, & Thoracic Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 29, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2017
• Results First Posted: August 4, 2016

Record last verified: 2017-12

Locations

US (1)