Optimal Pain Management After Video-Assisted Thoracic Surgery
- 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).
- 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
- 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.
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall consumption of narcotics between the 3 treatment arms
up to 24 hours after surgery
Todd L. Demmy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|