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

NCT00538499 | Completed DMC

• 2 other identifiers: CDR0000565803RPCI-I-37404
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Perioperative/Postoperative Complications

Keywords

pain; perioperative/postoperative complications

Outcome Measures

Primary Outcomes (1)

• Overall consumption of narcotics between the 3 treatment arms

  up to 24 hours after surgery

Secondary Outcomes (2)

• 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

Study Arms (3)

Fentanyl citrate

OTHER

Drug: Fentanyl citrate

bupivcaine hydrochloride

EXPERIMENTAL

Drug: Bupivacaine hydrocloride

videothoracoscopy

OTHER

Procedure: videothoracoscopy

Interventions

Fentanyl citrate DRUG

Fentanyl citrate

Bupivacaine hydrocloride DRUG

bupivcaine hydrochloride

videothoracoscopy PROCEDURE

videothoracoscopy

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Pain; Postoperative Complications

Interventions

Fentanyl; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Todd L. Demmy, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: October 28, 2004
• Primary Completion: July 27, 2007
• Study Completion: September 1, 2009
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)