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

NCT ID: NCT00538499

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-28
• Study Completion Date: 2009-09-30

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.

Conditions

Pain; Perioperative/Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl citrate

Group Type: OTHER

Fentanyl citrate

Intervention Type: DRUG

bupivcaine hydrochloride

Group Type: EXPERIMENTAL

Bupivacaine hydrocloride

Intervention Type: DRUG

videothoracoscopy

Group Type: OTHER

videothoracoscopy

Intervention Type: PROCEDURE

Interventions

Fentanyl citrate

Intervention Type: DRUG

Bupivacaine hydrocloride

Intervention Type: DRUG

videothoracoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd L. Demmy, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-37404

Identifier Type: -

Identifier Source: secondary_id

CDR0000565803

Identifier Type: -

Identifier Source: org_study_id