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

Pain Clinical Trial

Official title:

Optimal Pain Management After Video-Assisted Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538499
• Other study ID #: CDR0000565803
• Secondary ID: RPCI-I-37404
• Status: Completed
• Phase: N/A
• First received: October 1, 2007
• Last updated: February 8, 2017
• Start date: October 28, 2004
• Est. completion date: September 2009

Study information

• Verified date: February 2017
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: July 27, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Drug:
• Fentanyl citrate

• Bupivacaine hydrocloride

Procedure:
• videothoracoscopy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall consumption of narcotics between the 3 treatment arms		up to 24 hours after surgery
Secondary	Differences in Visual Analog Scale measurements between the 3 treatment arms		baseline and 6, 12, 18, and 24 hours post-surgery
Secondary	Rates of conversion and overall satisfaction with pain management		24 hours post-surgery