Continuous Subpleural Infusion of Bupivacaine
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2017 |
| Start Date: | October 2012 |
| End Date: | December 2015 |
A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy
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.
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.
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.
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.
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
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