Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00538499
First received: October 1, 2007
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain Perioperative/Postoperative Complications |
Drug: Fentanyl citrate Drug: Bupivacaine hydrocloride Procedure: videothoracoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Optimal Pain Management After Video-Assisted Thoracic Surgery |
Resource links provided by NLM:
Drug Information available for:
Fentanyl
Fentanyl citrate
Sodium citrate
Bupivacaine hydrochloride
Bupivacaine
U.S. FDA Resources
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Overall consumption of narcotics between the 3 treatment arms [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Differences in Visual Analog Scale measurements between the 3 treatment arms [ Time Frame: baseline and 6, 12, 18, and 24 hours post-surgery ] [ Designated as safety issue: No ]
- Rates of conversion and overall satisfaction with pain management [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | October 2004 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Fentanyl citrate | Drug: Fentanyl citrate |
| Experimental: bupivcaine hydrochloride | Drug: Bupivacaine hydrocloride |
| videothoracoscopy | Procedure: videothoracoscopy |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538499
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Todd L. Demmy, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00538499 History of Changes |
| Other Study ID Numbers: | CDR0000565803, RPCI-I-37404 |
| Study First Received: | October 1, 2007 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
pain perioperative/postoperative complications |
Additional relevant MeSH terms:
|
Postoperative Complications Pathologic Processes Bupivacaine Fentanyl Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Narcotics Analgesics Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013