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Optimal Pain Management After Video-Assisted Thoracic Surgery


N/A
N/A
N/A
Not Enrolling
Both
Pain, Perioperative/Postoperative Complications

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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 InstituteBuffalo, New York  14263