PainPhase 4VATS ExparelNCT02499159
Pain Management in Response to Exparel vs. Standard Bupivicaine
A Phase 4 study testing Liposomal Bupivicaine and 0.25% standard bupivicaine in people with Pain, run by Inova Health Care Services at 2 sites in United States.
Trial summary
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications. Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Liposomal Bupivicaine and 0.25% standard bupivicaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years of age
- Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Who cannot join
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
- Renal dysfunction (eGFR < 60ml/min/1.73m2)
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- History of peptic ulcerative disease
- Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
- Inability to consent
- Pregnancy
- Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
- Patient is discharged from the hospital with a chest tube in place
- Patient fails to comply with post-operative instructions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiac, Vascular, and Thoracic Surgery Associates
Falls Church, Virginia, 22042
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
Read the detailed description
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
- Conditions
- Pain
- Being tested
- Liposomal Bupivicaine, 0.25% standard bupivicaine
- Keywords
- Exparel, Thoracoscopy, Bupivicaine, Liposomal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivicaineDrug
Also called Exparel
266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
0.25% standard bupivicaineDrug
Also called Bupivicaine
standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Receives: Drug: Liposomal Bupivicaine |
| 0.25% standard bupivicaine | Active comparator | Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Receives: Drug: 0.25% standard bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.
Measured: Assessed daily for 7 days post-procedure
Secondary outcomes (9)
Scores on a Analog Pain Scale (7 Days)
Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.
Measured: Assessed at day 7 post-procedure
Scores on an Analog Pain Scale (30 Days)
Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.
Measured: Assessed at 30 days post-procedure
Number of Patients With Paresthesias (Postoperatively at 7 Days)
Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.
Measured: Assessed at day 7 post-procedure
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)
Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves
Measured: Assessed at day 30 post-procedure
Hospital Length of Stay
Median length of stay in days until discharge.
Measured: From end of procedure until discharge, usually 0-2 days.
Return to Baseline Activity
Using surveys, patients are asked if they have been able to return to baseline activity levels.
Measured: Assessed at 30 days post-procedure
Return to Work
Using surveys, patients are asked if they have been able to return to work.
Measured: Assessed at 30 days post-procedure
Days Until Return to Work
Using surveys, the number of days to return to work was assessed for patients who were able to return to work.
Measured: Assessed at 30 days post-procedure
Overall Hospital Cost
Overall hospital cost of patient procedure and stay will be assessed.
Measured: Total cost assessed from patient registration until discharge to home (usually 0-2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Mednax National Medical Group
- Responsible party
- Sponsor
- Investigators
- Sandeep J Khandhar, MD, Principal investigator, Cardiac, Vascular, and Thoracic Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499159
- Sponsor's protocol ID
- 14-1656
- Acronym
- VATS Exparel
- Status last verified
- Jan 2021
- First submitted
- 8 Jul 2015
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
PubMed 19022040Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
PubMed 19699918Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
PubMed 1914056Debreceni G, Molnar Z, Szelig L, Molnar TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. doi: 10.1034/j.1399-6576.2003.00208.x.
PubMed 12969101Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
PubMed 9725371American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
PubMed 15166580
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
- ClinicalTrials.gov ID
- NCT02499159
- Acronym / sponsor ID
- VATS Exparel / 14-1656
- Conditions
- Pain
- Keywords
- Exparel, Thoracoscopy, Bupivicaine, Liposomal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Mednax National Medical Group
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
Detailed description
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: Liposomal BupivicaineLiposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. |
| 0.25% standard bupivicaine | Active comparator | Drug: 0.25% standard bupivicaineBupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients over 18 years of age
- Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Key exclusion criteria (13 listed)
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
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 |
|---|---|---|
| Liposomal BupivicaineAlso: Exparel266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. | Drug | Exparel |
| 0.25% standard bupivicaineAlso: Bupivicainestandard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. | Drug | 0.25% standard bupivicaine |
Primary outcome
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
Time frame: Assessed daily for 7 days post-procedure
Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.
9 secondary outcomes
Scores on a Analog Pain Scale (7 Days)
Time frame: Assessed at day 7 post-procedure
Scores on an Analog Pain Scale (30 Days)
Time frame: Assessed at 30 days post-procedure
Number of Patients With Paresthesias (Postoperatively at 7 Days)
Time frame: Assessed at day 7 post-procedure
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)
Time frame: Assessed at day 30 post-procedure
Hospital Length of Stay
Time frame: From end of procedure until discharge, usually 0-2 days.
Return to Baseline Activity
Time frame: Assessed at 30 days post-procedure
Return to Work
Time frame: Assessed at 30 days post-procedure
Days Until Return to Work
Time frame: Assessed at 30 days post-procedure
Overall Hospital Cost
Time frame: Total cost assessed from patient registration until discharge to home (usually 0-2 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19022040Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
- Background: PubMed 19699918Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
- Background: PubMed 1914056Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
- Background: PubMed 12969101Debreceni G, Molnar Z, Szelig L, Molnar TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. doi: 10.1034/j.1399-6576.2003.00208.x.
- Background: PubMed 9725371Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
- Background: PubMed 15166580American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
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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.
Sandeep J Khandhar, MD principal investigator
Cardiac, Vascular, and Thoracic Surgery Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivicaine and 0.25% standard bupivicaine in people with Pain, run by Inova Health Care Services at 2 sites 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?
The sponsor lists 2 inclusion and 13 exclusion criteria. 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Amounts of Pain Medications Consumed Through Post-operative Day 7 (time frame: Assessed daily for 7 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499159, which also lists 6 linked publications.
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 16 Feb 2021.