Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery

Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Perioperative/Postoperative Complications

Pain

Treatments

Drug: Bupivacaine hydrocloride

Drug: Fentanyl citrate

Procedure: videothoracoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00538499

CDR0000565803

RPCI-I-37404

Details and patient eligibility

About

RATIONALE: Patient-controlled analgesia using fentanyl and bupivacaine may lessen pain caused by video-assisted chest surgery. Giving bupivacaine in different ways may give better pain relief.

PURPOSE: Thisrandomized clinical trial is comparing three different ways to give bupivacaine together with fentanyl to see how well they work in reducing pain after video-assisted chest surgery.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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