Continuous Subpleural Infusion of Bupivacaine

This study is currently recruiting participants.
Verified September 2013 by Inova Health Care Services
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01566838
First received: February 21, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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

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 overall use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital length of stay, and overall hospital cost.

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.


Condition Intervention
Postoperative Pain.
Drug: Subpleural pain catheter with infusion of 0.125% bupivacaine
Drug: Standard acute pain management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • Change from Baseline Narcotics Dose Administration at 1 week post-operative [ Time Frame: Postoperative day 1 through postoperative day 7 ] [ Designated as safety issue: No ]
    The primary outcome will measure narcotics administered (mg) from post-operative day 1 through post-operative day 7.


Secondary Outcome Measures:
  • Visual analog pain scores [ Time Frame: Postoperative day 1 through day 7, and postoperative day 30. ] [ Designated as safety issue: No ]
    Summed visual analog pain scores will be measured from post-operative day 1 through postoperative day 7, one final measure will be taken on post-operative day 30.

  • Length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
    Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.

  • Hospital cost [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Overall hospital cost will be calculated as a factor value.


Estimated Enrollment: 86
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: On-q pump
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
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.
Other Name: On-q pump
Active Comparator: Standard of care

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

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.


Detailed Description:

Video-Assisted Thoracic Surgery (VATS) has been shown to hasten patient recovery by attenuating the physiologic stress of surgery and decreasing post-operative pain. Despite this approach, incisions in the chest are proportionally more painful than in other parts of the body, and most patients require some form of narcotic pain medication.

Multiple strategies for post-operative pain control have been attempted in thoracic surgery with no obvious superiority of one versus another. Pain catheters have been increasingly used over the past decade in different surgical procedures in order to minimize incisional pain for the first 3 to 7 days after an operation. The published literature is equivocal as to the efficacy of such approach following thoracic surgery with most recent series reporting no benefit in the use of these catheters. Of utmost importance is the placement techniques described thus far, which in our opinion, have been suboptimal.

In order for a pain catheter to work, the infused local anesthetic has to constantly bathe the nerve in question thus preventing painful stimuli from being transmitted. It is hard to dispute the ability of local anesthetic to block pain conduction. Consequently, the success of the intervention is directly dependent on the placement technique to achieve such goal, hence the rationale for our study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566838

Contacts
Contact: Daniel L Fortes, MD 7032805858 dfortes@CVTSA.com

Locations
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Daniel L Fortes, MD    703-280-5858    dfortes@CVTSA.com   
Principal Investigator: Daniel L Fortes, MD         
Sponsors and Collaborators
Inova Health Care Services
Investigators
Principal Investigator: Daniel L Fortes, MD Cardiac, Vascular, & Thoracic Surgery Associates
  More Information

Publications:
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01566838     History of Changes
Other Study ID Numbers: 120104onq
Study First Received: February 21, 2012
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
Visual analog pain score
Length of stay
Hospital Cost
Subpleural pain catheter
Bupivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014