Bariatric Surgery CandidatePhase 4ExparelNCT03196505
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
A Phase 4 study testing Exparel 266 MG Per 20 ML Injection and Bupivacaine in people with Bariatric Surgery Candidate and Pain, Postoperative, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Pain, Postoperative
- What is being tested?
- Exparel 266 MG Per 20 ML Injection and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 31 Jul 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
- Fulfills NIH criteria for bariatric surgery
Who cannot join
- Patients deemed not a candidate for laparoscopic bariatric surgery
- Patients with previous bariatric or gastric surgeries.
- BMI <35 and > 60 kg/m2
- Preoperative inability to ambulate and confined to wheelchair.
- American Society of Anesthesiologist (ASA) score >3
- Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
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- Not able to understand informed consent, or unwilling to sign consent.
- Not able to understand and read English
- Currently pregnant or lactating.
- Age <18 or >65
- Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
- Patients requiring opiate use within 30 days prior to time of surgery.
- Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
- Patients with history of substance abuse, alcohol addiction
- Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
- Bupivacaine use within 96 hours before operation
- Prisoners
- Bariatric surgery operation >3 hours.
- More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
- Patients with renal failure or hepatic failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fresno Heart and Surgical Hospital
Fresno, California, 93720
About this study
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
- Conditions
- Bariatric Surgery Candidate, Pain, Postoperative
- Being tested
- Exparel 266 MG Per 20 ML Injection, Bupivacaine
- Keywords
- Anesthetics, Local, Liposomal Bupivacaine, Bupivacaine, Postoperative Complications, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Laparoscopic Bariatric Surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 266 MG Per 20 ML InjectionDrug
Also called EXPAREL
Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
BupivacaineDrug
Also called Marcaine
60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Receives: Drug: Exparel 266 MG Per 20 ML Injection |
| Control | Active comparator | 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalents
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
Measured: within 1 week post-operatively
Secondary outcomes (1)
Cumulative Pain Score
Average pain scores by blinded nurse obtained. Analogue pain rating scale ranged from 0 to 10 with 0 being no pain and 10 being the worst possible pain. Assessment of pain and nausea were performed every 4 hours after operation until discharge.
Measured: within 48 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start4 Dec 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pearl Ma, MD, Principal investigator, University of San Francisco - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196505
- Sponsor's protocol ID
- 2017061
- Acronym
- Exparel
- Status last verified
- Nov 2020
- First submitted
- 20 Jun 2017
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma P, Lloyd A, McGrath M, Shuchleib Cung A, Akusoba I, Jackson A, Swartz D, Boone K, Higa K. Efficacy of liposomal bupivacaine versus bupivacaine in port site injections on postoperative pain within enhanced recovery after bariatric surgery program: a randomized clinical trial. Surg Obes Relat Dis. 2019 Sep;15(9):1554-1562. doi: 10.1016/j.soard.2019.06.004. Epub 2019 Jun 17.
PubMed 31375443
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03196505
- Acronym / sponsor ID
- Exparel / 2017061
- Conditions
- Bariatric Surgery Candidate, Pain, Postoperative
- Keywords
- Anesthetics, Local, Liposomal Bupivacaine, Bupivacaine, Postoperative Complications, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Laparoscopic Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 25 Nov 2020
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 prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Drug: Exparel 266 MG Per 20 ML InjectionLiposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). |
| Control | Active comparator | Drug: Bupivacaine60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
- Fulfills NIH criteria for bariatric surgery
Key exclusion criteria (20 listed)
- Patients deemed not a candidate for laparoscopic bariatric surgery
- Patients with previous bariatric or gastric surgeries.
- BMI <35 and > 60 kg/m2
- Preoperative inability to ambulate and confined to wheelchair.
- American Society of Anesthesiologist (ASA) score >3
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 |
|---|---|---|
| Exparel 266 MG Per 20 ML InjectionAlso: EXPARELLiposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). | Drug | Liposomal Bupivacaine |
| BupivacaineAlso: Marcaine60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). | Drug | Control |
Primary outcome
Morphine Equivalents
Time frame: within 1 week post-operatively
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
1 secondary outcome
Cumulative Pain Score
Time frame: within 48 hours post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31375443Ma P, Lloyd A, McGrath M, Shuchleib Cung A, Akusoba I, Jackson A, Swartz D, Boone K, Higa K. Efficacy of liposomal bupivacaine versus bupivacaine in port site injections on postoperative pain within enhanced recovery after bariatric surgery program: a randomized clinical trial. Surg Obes Relat Dis. 2019 Sep;15(9):1554-1562. doi: 10.1016/j.soard.2019.06.004. Epub 2019 Jun 17.
- Individual participant dataSharing planned: No
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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.
Pearl Ma, MD principal investigator
University of San Francisco - Fresno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel 266 MG Per 20 ML Injection and Bupivacaine in people with Bariatric Surgery Candidate and Pain, Postoperative, run by University of California, San Francisco 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?
The sponsor lists 2 inclusion and 20 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 25 Nov 2020. 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.
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 25 Nov 2020). 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?
Morphine Equivalents (time frame: within 1 week post-operatively). 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 NCT03196505, which also lists 1 linked publication.
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 25 Nov 2020.