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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| No TAP block | No Intervention | Patients will be randomized to receive no TAP block as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine TAP block | Drug | Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl PCA mcg | Fentanyl PCA (patient controlled analgesia) total microgram usage. | 24 hours post surgery. |
| Total Fentanyl Usage | Total fentanyl usage in micrograms, including both PCA and IV push administered medication. | During hospitalization, up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Acetaminophen Usage | Total amount of acetaminophen used for analgesia. | During hospitalization, up t 7 days. |
| NSAID Usage | Total amount of NSAID (ketorolac) use for analgesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline. Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
| FG001 | Regular Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline. Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
| FG002 | No TAP Block | Patients were randomized to receive no TAP block as a control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline. Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fentanyl PCA mcg | Fentanyl PCA (patient controlled analgesia) total microgram usage. | Posted | Mean | Standard Deviation | Micrograms | 24 hours post surgery. |
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Up to 2 weeks post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB was composed of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline. Liposomal Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
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Further studies are needed to attempt to match patients based on variables that effect opiate metabolism and pain response, and to include alternative secondary outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diego Camacho, MD | Montefiore Medical Center | 718-920-4800 | dicamach@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2017 | Aug 12, 2019 | Prot_SAP_000.pdf |
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| Bupivacaine TAP block | Drug | Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
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| 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. | 24 hours post surgery. |
| Length of Stay | Hours of hospitalization post-surgery | 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. | 24 hours post surgery. |
| Time to Ambulation | Assessed every 24 hours post surgery, up to 168 hour post-surgery. |
| BG001 | Regular Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline. Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. |
| BG002 | No TAP Block | Patients were randomized to receive no TAP block as a control group. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | Kilograms |
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| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
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| Procedure | Count of Participants | Participants |
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| OG002 | No TAP Block | Patients were randomized to receive no TAP block as a control group. |
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| Primary | Total Fentanyl Usage | Total fentanyl usage in micrograms, including both PCA and IV push administered medication. | Posted | Mean | Standard Deviation | Micrograms | During hospitalization, up to 7 days. |
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| Secondary | Acetaminophen Usage | Total amount of acetaminophen used for analgesia. | Posted | Mean | Standard Deviation | Miligrams | During hospitalization, up t 7 days. |
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| Secondary | NSAID Usage | Total amount of NSAID (ketorolac) use for analgesia. | Posted | Mean | Standard Deviation | Miligrams | During hospitalization, up to 7 days. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours post surgery. |
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| Secondary | Length of Stay | Hours of hospitalization post-surgery | Posted | Count of Participants | Participants | Assessed every 24 hours post surgery, up to 168 hour post-surgery. |
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| Secondary | Nausea | Number of participants with presence or absence of nausea reported and recorded by the nurse. | Posted | Count of Participants | Participants | 24 hours post surgery. |
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| Secondary | Time to Ambulation | Posted | Mean | Standard Deviation | Hours | Assessed every 24 hours post surgery, up to 168 hour post-surgery. |
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| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Regular Bupivacaine TAP Block | Patients were randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB was composed of 50mL of 0.25% bupivacaine and 100mL of normal saline. Bupivacaine TAP block: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization. | 0 | 71 | 0 | 71 | 0 | 71 |
| EG002 | No TAP Block | Patients were randomized to receive no TAP block as a control group. | 0 | 73 | 0 | 73 | 0 | 73 |
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| 72 hours |
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| 96 hours |
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| 120 hours |
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| 168 hours |
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