Pain, PostoperativePhase 4NCT01853176
Exparel vs. Standard Bupivicaine for Abdominoplasty
A Phase 4 study testing Liposomal Injection Bupivacaine (Exparel) and Standard bupivicaine in people with Pain, Postoperative, run by Emory University at 3 sites in United States.
Trial summary
Background \& study question: Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects, which include drowsiness, nausea, and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Liposomal Injection Bupivacaine (Exparel) and Standard bupivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to Jul 2014
- 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
- adult men and women
- scheduled for abdominoplasty
Who cannot join
- pregnant women
- patients with allergy to amide-type local anesthetics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Emory Aesthetic Center at Paces
Atlanta, Georgia, 30327
About this study
Official title: Is Liposomal Injection Bupivacaine (Exparel) Superior to Standard Bupivacaine for Abdominoplasty? A Randomized Controlled Trial
Background \& study question:
Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects, which include drowsiness, nausea, and vomiting. A key element of these strategies is wound injection with local anesthetic (numbing medicine) at the time of surgery. Local numbing procedures are used routinely in patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several hours. Multiple studies have shown that locally injected pain medicines achieve better pain control, less opioid use, and faster return to normal activities, such that the use of one of these local anesthetic medicines is the current standard of care.
Read more
Exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours. Studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents. Exparel has been used successfully in a variety of surgical settings, including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast augmentation. Its effectiveness has by and large been established in comparison to no local anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty.
Study design:
Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel by coin toss after their clinic visit. On the day of surgery, the only difference between patients assigned to one arm or the other is the local anesthetic used. The surgery itself and plan for general anesthesia will be similar. Both groups will have the same pain medicines available after surgery.
Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use will be collected from their inpatient medical record.
The primary outcome of interest is daily and cumulative pain scores through 3 days. A secondary endpoint is daily and total opioid use over 3 days. Additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects.
- Conditions
- Pain, Postoperative
- Being tested
- Liposomal Injection Bupivacaine (Exparel), Standard bupivicaine
- Keywords
- Pain, Postoperative, Analgesia, Anesthesia, local, Abdominoplasty
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Injection Bupivacaine (Exparel)Drug
Also called Exparel, bupivicaine liposome injectable suspension
Standard bupivicaineDrug
Also called bupivicaine, Marcaine
| Study group | Role | What they receive |
|---|---|---|
| Liposomal injection bupivicaine (Exparel) | Experimental | Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty. Receives: Drug: Liposomal Injection Bupivacaine (Exparel) |
| Standard bupivicaine | Active comparator | Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty. Receives: Drug: Standard bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score, Visual Analogue Pain Scores
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: required documentation too onerous
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 (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Losken, MD, Emory University
- Investigators
- Albert Losken, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853176
- Sponsor's protocol ID
- IRB00064693
- Status last verified
- Oct 2014
- First submitted
- 10 May 2013
- Last updated
- 3 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
PubMed 22067185Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.
PubMed 22546131Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
PubMed 22900785Chavez-Abraham V, Barr JS, Zwiebel PC. The efficacy of a lidocaine-infused pain pump for postoperative analgesia following elective augmentation mammaplasty or abdominoplasty. Aesthetic Plast Surg. 2011 Aug;35(4):463-9. doi: 10.1007/s00266-010-9633-4. Epub 2010 Dec 7.
PubMed 21136251Feng LJ. Painless abdominoplasty: the efficacy of combined intercostal and pararectus blocks in reducing postoperative pain and recovery time. Plast Reconstr Surg. 2010 Nov;126(5):1723-1732. doi: 10.1097/PRS.0b013e3181ef8fe5.
PubMed 21042130
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Liposomal Injection Bupivacaine (Exparel) Superior to Standard Bupivacaine for Abdominoplasty? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01853176
- Acronym / sponsor ID
- IRB00064693
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Postoperative, Analgesia, Anesthesia, local, Abdominoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: required documentation too onerous
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background \& study question:
Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects, which include drowsiness, nausea, and vomiting. A key element of these strategies is wound injection with local anesthetic (numbing medicine) at the time of surgery. Local numbing procedures are used routinely in patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several hours. Multiple studies have shown that locally injected pain medicines achieve better pain control, less opioid use, and faster return to normal activities, such that the use of one of these local anesthetic medicines is the current standard of care.
Exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours. Studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents. Exparel has been used successfully in a variety of surgical settings, including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast augmentation. Its effectiveness has by and large been established in comparison to no local anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty.
Study design:
Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel by coin toss after their clinic visit. On the day of surgery, the only difference between patients assigned to one arm or the other is the local anesthetic used. The surgery itself and plan for general anesthesia will be similar. Both groups will have the same pain medicines available after surgery.
Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use will be collected from their inpatient medical record.
The primary outcome of interest is daily and cumulative pain scores through 3 days. A secondary endpoint is daily and total opioid use over 3 days. Additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal injection bupivicaine (Exparel) | Experimental | Drug: Liposomal Injection Bupivacaine (Exparel)Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty. |
| Standard bupivicaine | Active comparator | Drug: Standard bupivicainePatients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult men and women
- scheduled for abdominoplasty
Key exclusion criteria (2 listed)
- pregnant women
- patients with allergy to amide-type local anesthetics
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 Injection Bupivacaine (Exparel)Also: Exparel, bupivicaine liposome injectable suspension | Drug | Liposomal injection bupivicaine (Exparel) |
| Standard bupivicaineAlso: bupivicaine, Marcaine | Drug | Standard bupivicaine |
Primary outcome
Pain Score, Visual Analogue Pain Scores
Time frame: 3 days
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22067185Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
- Background: PubMed 22546131Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.
- Background: PubMed 22900785Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
- Background: PubMed 21136251Chavez-Abraham V, Barr JS, Zwiebel PC. The efficacy of a lidocaine-infused pain pump for postoperative analgesia following elective augmentation mammaplasty or abdominoplasty. Aesthetic Plast Surg. 2011 Aug;35(4):463-9. doi: 10.1007/s00266-010-9633-4. Epub 2010 Dec 7.
- Background: PubMed 21042130Feng LJ. Painless abdominoplasty: the efficacy of combined intercostal and pararectus blocks in reducing postoperative pain and recovery time. Plast Reconstr Surg. 2010 Nov;126(5):1723-1732. doi: 10.1097/PRS.0b013e3181ef8fe5.
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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.
Albert Losken, MD principal investigator
Emory University
3 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 Injection Bupivacaine (Exparel) and Standard bupivicaine in people with Pain, Postoperative, run by Emory University at 3 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 2 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: stopped early, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 3 Nov 2014). 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?
Pain Score, Visual Analogue Pain Scores (time frame: 3 days). 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 NCT01853176, which also lists 5 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 3 Nov 2014.