Clinical trial NCT00538499: Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
Official title: Optimal Pain Management After Video-Assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Perioperative/Postoperative Complications
Keywords: pain
perioperative/postoperative complications
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 30
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Overall consumption of narcotics between the 3 treatment arms
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Differences in Visual Analog Scale measurements between the 3 treatment arms
timeFrame: baseline and 6, 12, 18, and 24 hours post-surgery
measure: Rates of conversion and overall satisfaction with pain management
timeFrame: 24 hours post-surgery
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Todd L. Demmy, MD
role: PRINCIPAL_INVESTIGATOR
References: