PainNCT00538499
Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
A study testing Fentanyl citrate, Bupivacaine hydrocloride and videothoracoscopy in people with Pain and Perioperative/Postoperative Complications, run by Roswell Park Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Pain, Perioperative/Postoperative Complications
- What is being tested?
- Fentanyl citrate, Bupivacaine hydrocloride and videothoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2004to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: 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.
Read the 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
- Being tested
- Fentanyl citrate, Bupivacaine hydrocloride, videothoracoscopy
- Keywords
- pain, perioperative/postoperative complications
- Medical subject headings
- Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl citrateDrug
Bupivacaine hydroclorideDrug
videothoracoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl citrate | Other | Not described Receives: Drug: Fentanyl citrate |
| bupivcaine hydrochloride | Experimental | Not described Receives: Drug: Bupivacaine hydrocloride |
| videothoracoscopy | Other | Not described Receives: Procedure: videothoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall consumption of narcotics between the 3 treatment arms
Measured: up to 24 hours after surgery
Secondary outcomes (2)
Differences in Visual Analog Scale measurements between the 3 treatment arms
Measured: baseline and 6, 12, 18, and 24 hours post-surgery
Rates of conversion and overall satisfaction with pain management
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study start28 Oct 2004
- Primary completion27 Jul 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd L. Demmy, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538499
- Sponsor's protocol ID
- CDR0000565803
- Other IDs
- RPCI-I-37404
- Status last verified
- Feb 2017
- First submitted
- 1 Oct 2007
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Pain Management After Video-Assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00538499
- Acronym / sponsor ID
- CDR0000565803
- Conditions
- Pain, Perioperative/Postoperative Complications
- Keywords
- pain, perioperative/postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 28 Oct 2004 (actual)
- Primary completion
- 27 Jul 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fentanyl citrate | Other | Drug: Fentanyl citrate |
| bupivcaine hydrochloride | Experimental | Drug: Bupivacaine hydrocloride |
| videothoracoscopy | Other | Procedure: videothoracoscopy |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl citrate | Drug | Fentanyl citrate |
| Bupivacaine hydrocloride | Drug | bupivcaine hydrochloride |
| videothoracoscopy | Procedure or surgery | videothoracoscopy |
Primary outcome
Overall consumption of narcotics between the 3 treatment arms
Time frame: up to 24 hours after surgery
2 secondary outcomes
Differences in Visual Analog Scale measurements between the 3 treatment arms
Time frame: baseline and 6, 12, 18, and 24 hours post-surgery
Rates of conversion and overall satisfaction with pain management
Time frame: 24 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd L. Demmy, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl citrate, Bupivacaine hydrocloride and videothoracoscopy in people with Pain and Perioperative/Postoperative Complications, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall consumption of narcotics between the 3 treatment arms (time frame: up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.