Skip to main content
OpenTrials
Completed

NCT Number: NCT01566838

Continuous Subpleural Infusion of Bupivacaine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Primary outcomes

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

    Time frame: Postoperative day 1 through postoperative day 30

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

Secondary outcomes

  1. 7-day Paresthesia

    Time frame: Postoperative day 1 through day 7

    Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7

  2. Length of Stay

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

    Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.

  3. 30-day Incidence of Parasthesia

    Time frame: 30 days

    30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)

  4. Return to Work

    Time frame: 30 days

    Returned to work in 30 days?

  5. Resumed Physical Activity

    Time frame: 30 days

    Did the patient resume physical activity.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2012
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.