Optimal Pain Management After Video-Assisted Thoracic Surgery
N/A
N/A
Both
Pain, Perioperative/Postoperative Complications
Trial Information
Optimal Pain Management After Video-Assisted Thoracic Surgery
OBJECTIVES:
Primary
- To compare the efficacy of intravenous, patient-controlled, narcotic pain management
alone to the efficacy of intermittent bolus injection of bupivacaine hydrochloride via
an intrapleural catheter in patients who have successfully undergone video-assisted
thoracic surgery (VATS).
Secondary
- To compare the efficacy of intermittent bolus administration of bupivacaine
hydrochloride to the efficacy of continuous bupivacaine hydrochloride administration
via an intrapleural catheter in patients who have successfully undergone VATS.
- To compare visual analog scale pain scores at all measurement times.
- To compare patient satisfaction scores for each method of pain control.
- To compare rates of conversion from bolus delivery to intravenous narcotic delivery.
- To compare rates of conversion from continuous intrapleural infusion to bolus delivery
or intravenous narcotic delivery alone.
- To compare the total amount of narcotics used between bolus intrapleural delivery and
continuous intrapleural infusion.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive intravenous patient-controlled analgesia (IV-PCA) fentanyl
citrate beginning once the patient is awake and alert after surgery and continuing for
24 hours.
- Arm II: Patients receive intermittent intrapleural bolus bupivacaine hydrochloride
immediately after surgery and then at 6, 12, 18, and 24 hours after surgery and IV-PCA
fentanyl citrate as in arm I.
- Arm III: Patients receive a continuous infusion of intrapleural bupivacaine
hydrochloride beginning immediately after surgery and continuing for 24 hours and
IV-PCA fentanyl citrate as in arm I.
In all arms, visual analog scale measurements are taken at baseline and 6, 12, 18, and 24
hours post-surgery. After 24 hours, a 5-point Likert scale survey is administered to assess
overall patient satisfaction with pain control in the 24-hour postoperative period.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Candidate for video-assisted thoracic surgery (VATS) and unlikely to require
conversion to open thoracotomy as determined by physician
- Able to satisfactorily complete a Visual Analog Scale (VAS) measurement
- Patients who are too sedated postoperatively or who are unable to properly mark
a VAS scale due to other factors (poor eyesight, lack of manual dexterity, or
lack of comprehension of the test) are ineligible
PATIENT CHARACTERISTICS:
- No allergy to bupivacaine hydrochloride or fentanyl citrate
- No known renal or liver disease (i.e., hepatic insufficiency or cirrhosis) that would
affect metabolism of drugs used in this study
- Not pregnant or nursing
- Negative pregnancy test
- No thoracic infection within the past 3 months
- Weight ≥ 55 kg
- ALT and AST < 10% of upper limit of normal
- Serum creatinine < 1.5 mg/dL
- BUN < 40 mg/dL
PRIOR CONCURRENT THERAPY:
- No concurrent narcotics for pain management
- No concurrent amiodarone, barbiturate anesthetics or other CNS depressants, diazepam,
droperidol, nitrous oxide, or protease inhibitors
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall consumption of narcotics between the 3 treatment arms
Outcome Time Frame:
up to 24 hours after surgery
Safety Issue:
No
Principal Investigator
Todd L. Demmy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000565803
NCT ID:
NCT00538499
Start Date:
October 2004
Completion Date:
September 2009
Related Keywords:
- Pain
- Perioperative/Postoperative Complications
- pain
- perioperative/postoperative complications
- Postoperative Complications
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
