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

Optimal Pain Management After Video-Assisted Thoracic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain; Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: videothoracoscopy; Drug: Fentanyl citrate; Drug: Bupivacaine hydrocloride

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fentanyl citrate	Drug: Fentanyl citrate
Experimental: bupivcaine hydrochloride	Drug: Bupivacaine hydrocloride
Other: videothoracoscopy	Procedure: videothoracoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall consumption of narcotics between the 3 treatment arms	up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences in Visual Analog Scale measurements between the 3 treatment arms	baseline and 6, 12, 18, and 24 hours post-surgery
Rates of conversion and overall satisfaction with pain management	24 hours post-surgery

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2004
• Primary Completion (Actual): July 27, 2007
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 1, 2007
• First Submitted That Met QC Criteria: October 1, 2007
• First Posted (Estimate): October 2, 2007

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: pain; perioperative/postoperative complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: CDR0000565803; RPCI-I-37404