Post Operative PainPhase 4NCT02752230
Comparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics
A Phase 4 study testing Laparoscopic Roux en Y gastric bypass and Laparoscopic Sleeve Gastrectomy in people with Post Operative Pain, run by Kettering Health Network.
Trial summary
This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Laparoscopic Roux en Y gastric bypass and Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2016to 1 Jun 2021
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer
Who cannot join
- Patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain.
- Patients with complex medical conditions that may confound data analysis per the principal investigator's discretion.
- Any pregnant patient.Any patients that would not like to participate in the study.
- Any patient that is not able to read or understand English
About this study
Official title: Comparison of Exparel (Bupivacaine Liposome) to Marcaine (Bupivacaine) in Post-Surgical Analgesia for Laparoscopic Trocar Site Incisions in Bariatric Surgery
This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. The intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.
- Conditions
- Post Operative Pain
- Being tested
- Laparoscopic Roux en Y gastric bypass, Laparoscopic Sleeve Gastrectomy
- Keywords
- Post operative pain, Bariatric Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux en Y gastric bypassProcedure or surgery
Laparoscopic Roux en Y gastric bypass
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic Sleeve Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Exparel (Bupivicaine Liposome) | Active comparator | Patient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. Receives: Procedure: Laparoscopic Roux en Y gastric bypass; Procedure: Laparoscopic Sleeve Gastrectomy |
| Marcaine (Bupivicaine) | Active comparator | Patient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. Receives: Procedure: Laparoscopic Roux en Y gastric bypass; Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Post Operative Pain Level
Post operative pain will be assessed on an subjective level. The patient's pain will be assessed by the use of the Wong-Baker pain scale.
Measured: Within the first 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start29 Nov 2016
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: Attending physician left network
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Smith, Kettering Health Network
- Investigators
- Lauren Smith, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752230
- Sponsor's protocol ID
- 717168-2
- Status last verified
- Jul 2020
- First submitted
- 31 Mar 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233McGee, DL. Local and topical anesthesia in clinical procedures in Emergency Medicine, 5th edition, Roberts, JR, 263Hedges, JR(Eds), Saunders Elsevier, Philadelphia 2010, pg. 481
Weingart SN, Iezzoni LI, Davis RB, Palmer RH, Cahalane M, Hamel MB, Mukamal K, Phillips RS, Davies DT Jr, Banks NJ. Use of administrative data to find substandard care: validation of the complications screening program. Med Care. 2000 Aug;38(8):796-806. doi: 10.1097/00005650-200008000-00004.
PubMed 10929992Fleischmann KE, Goldman L, Young B, Lee TH. Association between cardiac and noncardiac complications in patients undergoing noncardiac surgery: outcomes and effects on length of stay. Am J Med. 2003 Nov;115(7):515-20. doi: 10.1016/s0002-9343(03)00474-1.
PubMed 14599629Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004 Oct;199(4):531-7. doi: 10.1016/j.jamcollsurg.2004.05.276.
PubMed 15454134
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exparel (Bupivacaine Liposome) to Marcaine (Bupivacaine) in Post-Surgical Analgesia for Laparoscopic Trocar Site Incisions in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02752230
- Acronym / sponsor ID
- 717168-2
- Conditions
- Post Operative Pain
- Keywords
- Post operative pain, Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Attending physician left network
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 26 Apr 2016 (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.
This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. The intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel (Bupivicaine Liposome) | Active comparator | Procedure: Laparoscopic Roux en Y gastric bypass, Procedure: Laparoscopic Sleeve GastrectomyPatient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. |
| Marcaine (Bupivicaine) | Active comparator | Procedure: Laparoscopic Roux en Y gastric bypass, Procedure: Laparoscopic Sleeve GastrectomyPatient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer
Key exclusion criteria (4 listed)
- Patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain.
- Patients with complex medical conditions that may confound data analysis per the principal investigator's discretion.
- Any pregnant patient.Any patients that would not like to participate in the study.
- Any patient that is not able to read or understand English
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 |
|---|---|---|
| Laparoscopic Roux en Y gastric bypassLaparoscopic Roux en Y gastric bypass | Procedure or surgery | Exparel (Bupivicaine Liposome), Marcaine (Bupivicaine) |
| Laparoscopic Sleeve GastrectomyLaparoscopic Sleeve Gastrectomy | Procedure or surgery | Exparel (Bupivicaine Liposome), Marcaine (Bupivicaine) |
Primary outcome
Subjective Post Operative Pain Level
Time frame: Within the first 10 days after surgery
Post operative pain will be assessed on an subjective level. The patient's pain will be assessed by the use of the Wong-Baker pain scale.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- BackgroundMcGee, DL. Local and topical anesthesia in clinical procedures in Emergency Medicine, 5th edition, Roberts, JR, 263Hedges, JR(Eds), Saunders Elsevier, Philadelphia 2010, pg. 481
- Background: PubMed 10929992Weingart SN, Iezzoni LI, Davis RB, Palmer RH, Cahalane M, Hamel MB, Mukamal K, Phillips RS, Davies DT Jr, Banks NJ. Use of administrative data to find substandard care: validation of the complications screening program. Med Care. 2000 Aug;38(8):796-806. doi: 10.1097/00005650-200008000-00004.
- Background: PubMed 14599629Fleischmann KE, Goldman L, Young B, Lee TH. Association between cardiac and noncardiac complications in patients undergoing noncardiac surgery: outcomes and effects on length of stay. Am J Med. 2003 Nov;115(7):515-20. doi: 10.1016/s0002-9343(03)00474-1.
- Background: PubMed 15454134Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004 Oct;199(4):531-7. doi: 10.1016/j.jamcollsurg.2004.05.276.
- CDCLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Lauren Smith principal investigator
Kettering Health Network
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Roux en Y gastric bypass and Laparoscopic Sleeve Gastrectomy in people with Post Operative Pain, run by Kettering Health Network.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Subjective Post Operative Pain Level (time frame: Within the first 10 days after surgery). 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 NCT02752230, 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 15 Jul 2020.