Bariatric Surgery AnalgesiaPhase 2NCT03373591
Liposomal Bupivacaine in Bariatric Surgery
A Phase 2 study testing Liposomal Bupivacaine TAP block and Bupivacaine TAP block in people with Bariatric Surgery Analgesia, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Analgesia
- What is being tested?
- Liposomal Bupivacaine TAP block and Bupivacaine TAP block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 31 Dec 2018
- Phase
- Phase 2
- 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
- Obese patients undergoing bariatric surgery (LSG or LRYGB)
- Patients 18 years of age and older
- Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period
Who cannot join
- Patients under the age of 18 years old
- Patients taking any opiates within 30 days of enrollment in the trial
- Patients with a history of chronic pain.
- Patients taking pregabalin or gabapentin.
- ASA IV
- Prior laparotomy
Show all 10Show fewer
- Body Mass Index ≥ 60 kg/m2
- History of cardiac arrhythmia
- History of Seizure
- Psychiatric Diagnosis currently on antipsychotic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.
Read the detailed description
A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.
- Conditions
- Bariatric Surgery Analgesia
- Being tested
- Liposomal Bupivacaine TAP block, Bupivacaine TAP block
- Keywords
- bariatric surgery, liposomal bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine TAP blockDrug
Also called Exparel TAP block
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
Bupivacaine TAP blockDrug
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine TAP block | Experimental | Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline. Receives: Drug: Liposomal Bupivacaine TAP block |
| Regular Bupivacaine TAP block | Active comparator | Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline. Receives: Drug: Bupivacaine TAP block |
| No TAP block | No intervention | Patients will be randomized to receive no TAP block as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl PCA mcg
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Measured: 24 hours post surgery.
Total Fentanyl Usage
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
Measured: During hospitalization, up to 7 days.
Secondary outcomes (6)
Acetaminophen Usage
Total amount of acetaminophen used for analgesia.
Measured: During hospitalization, up t 7 days.
NSAID Usage
Total amount of NSAID (ketorolac) use for analgesia.
Measured: During hospitalization, up to 7 days.
Pain Score
Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.
Measured: 24 hours post surgery.
Length of Stay
Hours of hospitalization post-surgery
Measured: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Nausea
Number of participants with presence or absence of nausea reported and recorded by the nurse.
Measured: 24 hours post surgery.
Time to Ambulation
Measured: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start30 Jan 2018
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
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.
- Other trials for Bariatric Surgery AnalgesiaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Camacho, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373591
- Sponsor's protocol ID
- 2017-7706
- Status last verified
- Oct 2019
- First submitted
- 9 Dec 2017
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03373591
- Acronym / sponsor ID
- 2017-7706
- Conditions
- Bariatric Surgery Analgesia
- Keywords
- bariatric surgery, liposomal bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.
Detailed description
A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine TAP block | Experimental | Drug: Liposomal Bupivacaine TAP blockPatients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline. |
| Regular Bupivacaine TAP block | Active comparator | Drug: Bupivacaine TAP blockPatients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline. |
| No TAP block | No intervention | –Patients will be randomized to receive no TAP block as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese patients undergoing bariatric surgery (LSG or LRYGB)
- Patients 18 years of age and older
- Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period
Key exclusion criteria (10 listed)
- Patients under the age of 18 years old
- Patients taking any opiates within 30 days of enrollment in the trial
- Patients with a history of chronic pain.
- Patients taking pregabalin or gabapentin.
- ASA IV
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 Bupivacaine TAP blockAlso: Exparel TAP blockInfiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. | Drug | Liposomal Bupivacaine TAP block |
| Bupivacaine TAP blockInfiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. | Drug | Regular Bupivacaine TAP block |
Primary outcome
Fentanyl PCA mcg
Time frame: 24 hours post surgery.
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Total Fentanyl Usage
Time frame: During hospitalization, up to 7 days.
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
6 secondary outcomes
Acetaminophen Usage
Time frame: During hospitalization, up t 7 days.
NSAID Usage
Time frame: During hospitalization, up to 7 days.
Pain Score
Time frame: 24 hours post surgery.
Length of Stay
Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Nausea
Time frame: 24 hours post surgery.
Time to Ambulation
Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery Analgesia
Not yet recruiting
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia
Anesthesia, Bariatric Surgery (Gastric Bypass)
RecruitingPhase 3
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
Pain Management, Overweight , Obesity
Not yet recruiting
Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy
Obesity Postoperative Pain, Obesity Morbid Obesity Postoperative Pain
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
Not yet recruiting
Rectus Sheath Block Versus Transversus Abdominis Plane Block for Analgesia in Laparoscopic Bariatric Surgery
Rectus Sheath Block, Transverse Abdominis Plane Block
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Bupivacaine TAP block and Bupivacaine TAP block in people with Bariatric Surgery Analgesia, run by Montefiore Medical Center 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 3 inclusion and 10 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 4 Nov 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Nov 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?
Fentanyl PCA mcg (time frame: 24 hours post surgery.). The study lists 2 primary outcomes in all. 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 4 Nov 2019.