Brief 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®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.
Brief Title
Liposomal Bupivacaine in Bariatric Surgery
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.
Completion Date
Completion Date Type
Actual
Conditions
Bariatric Surgery Analgesia
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Body Mass Index ≥ 60 kg/m2
* History of cardiac arrhythmia
* History of Seizure
* Psychiatric Diagnosis currently on antipsychotic medication
* 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
Exclusion Criteria:
* 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
* Body Mass Index ≥ 60 kg/m2
* History of cardiac arrhythmia
* History of Seizure
* Psychiatric Diagnosis currently on antipsychotic medication
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Keywords
bariatric surgery
liposomal bupivacaine
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03373591
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7706
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
Primary Outcomes
Outcome Description
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Outcome Measure
Fentanyl PCA mcg
Outcome Time Frame
24 hours post surgery.
Outcome Description
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
Outcome Measure
Total Fentanyl Usage
Outcome Time Frame
During hospitalization, up to 7 days.
Secondary Outcomes
Outcome Description
Total amount of acetaminophen used for analgesia.
Outcome Time Frame
During hospitalization, up t 7 days.
Outcome Measure
Acetaminophen Usage
Outcome Description
Total amount of NSAID (ketorolac) use for analgesia.
Outcome Time Frame
During hospitalization, up to 7 days.
Outcome Measure
NSAID Usage
Outcome Description
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.
Outcome Time Frame
24 hours post surgery.
Outcome Measure
Pain Score
Outcome Description
Hours of hospitalization post-surgery
Outcome Time Frame
Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Outcome Measure
Length of Stay
Outcome Description
Number of participants with presence or absence of nausea reported and recorded by the nurse.
Outcome Time Frame
24 hours post surgery.
Outcome Measure
Nausea
Outcome Time Frame
Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Outcome Measure
Time to Ambulation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Diego Camacho
Investigator Email
dicamach@montefiore.org
Investigator Phone
718-920-6755