Bariatric Surgery Analgesia
Conditions
Keywords
bariatric surgery, liposomal bupivacaine
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.
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.
Interventions
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
DRUGBupivacaine TAP block
Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl PCA mcg | 24 hours post surgery. | Fentanyl PCA (patient controlled analgesia) total microgram usage. |
| Total Fentanyl Usage | During hospitalization, up to 7 days. | Total fentanyl usage in micrograms, including both PCA and IV push administered medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 24 hours post surgery. | 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. |
| Length of Stay | Assessed every 24 hours post surgery, up to 168 hour post-surgery. | Hours of hospitalization post-surgery |
| Acetaminophen Usage | During hospitalization, up t 7 days. | Total amount of acetaminophen used for analgesia. |
| Time to Ambulation | Assessed every 24 hours post surgery, up to 168 hour post-surgery. | — |
| Nausea | 24 hours post surgery. | Number of participants with presence or absence of nausea reported and recorded by the nurse. |
| NSAID Usage | During hospitalization, up to 7 days. | Total amount of NSAID (ketorolac) use for analgesia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| 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. | 71 |
| No TAP Block Patients were randomized to receive no TAP block as a control group. | 73 |
| Total | 219 |
Baseline characteristics
| Characteristic | No TAP Block | Regular Bupivacaine TAP Block | Liposomal Bupivacaine TAP Block | Total |
|---|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 11 | 39.4 years STANDARD_DEVIATION 10.9 | 42.1 years STANDARD_DEVIATION 9.8 | 40.6 years STANDARD_DEVIATION 10.6 |
| BMI (Body Mass Index) | 44.2 kg/m^2 STANDARD_DEVIATION 5.5 | 44.8 kg/m^2 STANDARD_DEVIATION 5.5 | 44.5 kg/m^2 STANDARD_DEVIATION 7.6 | 44.5 kg/m^2 STANDARD_DEVIATION 6.2 |
| Procedure Gastric Bypass | 21 Participants | 16 Participants | 15 Participants | 52 Participants |
| Procedure Sleeve Gastrectomy | 50 Participants | 55 Participants | 55 Participants | 160 Participants |
| Procedure Sleeve to Bypass Conversion | 2 Participants | 0 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 26 Participants | 25 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 39 Participants | 40 Participants | 34 Participants | 113 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 4 Participants | 16 Participants | 27 Participants |
| Region of Enrollment United States | 73 participants | 71 participants | 75 participants | 219 participants |
| Sex: Female, Male Female | 66 Participants | 55 Participants | 60 Participants | 181 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 15 Participants | 38 Participants |
| Weight | 116.6 Kilograms STANDARD_DEVIATION 20.2 | 121.7 Kilograms STANDARD_DEVIATION 22.6 | 119.5 Kilograms STANDARD_DEVIATION 23.8 | 119.3 Kilograms STANDARD_DEVIATION 22.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 71 | 0 / 73 |
| other Total, other adverse events | 0 / 75 | 0 / 71 | 0 / 73 |
| serious Total, serious adverse events | 0 / 75 | 0 / 71 | 0 / 73 |
Outcome results
Primary
Fentanyl PCA mcg
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Time frame: 24 hours post surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Fentanyl PCA mcg | 351.4 Micrograms | Standard Deviation 209.4 |
| Regular Bupivacaine TAP Block | Fentanyl PCA mcg | 360.7 Micrograms | Standard Deviation 223.5 |
| No TAP Block | Fentanyl PCA mcg | 353.9 Micrograms | Standard Deviation 231 |
Primary
Total Fentanyl Usage
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
Time frame: During hospitalization, up to 7 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Total Fentanyl Usage | 424.1 Micrograms | Standard Deviation 222.9 |
| Regular Bupivacaine TAP Block | Total Fentanyl Usage | 434.2 Micrograms | Standard Deviation 237.4 |
| No TAP Block | Total Fentanyl Usage | 427.5 Micrograms | Standard Deviation 245.8 |
Secondary
Acetaminophen Usage
Total amount of acetaminophen used for analgesia.
Time frame: During hospitalization, up t 7 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Acetaminophen Usage | 486.4 Miligrams | Standard Deviation 553.1 |
| Regular Bupivacaine TAP Block | Acetaminophen Usage | 501.0 Miligrams | Standard Deviation 456 |
| No TAP Block | Acetaminophen Usage | 353.4 Miligrams | Standard Deviation 486.9 |
Secondary
Length of Stay
Hours of hospitalization post-surgery
Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Length of Stay | 48 hours | 26 Participants |
| Liposomal Bupivacaine TAP Block | Length of Stay | 120 hours | 1 Participants |
| Liposomal Bupivacaine TAP Block | Length of Stay | 96 hours | 1 Participants |
| Liposomal Bupivacaine TAP Block | Length of Stay | 24 hours | 42 Participants |
| Liposomal Bupivacaine TAP Block | Length of Stay | 168 hours | 0 Participants |
| Liposomal Bupivacaine TAP Block | Length of Stay | 72 hours | 5 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 96 hours | 0 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 24 hours | 44 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 48 hours | 26 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 72 hours | 1 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 120 hours | 0 Participants |
| Regular Bupivacaine TAP Block | Length of Stay | 168 hours | 0 Participants |
| No TAP Block | Length of Stay | 168 hours | 1 Participants |
| No TAP Block | Length of Stay | 120 hours | 0 Participants |
| No TAP Block | Length of Stay | 24 hours | 46 Participants |
| No TAP Block | Length of Stay | 48 hours | 25 Participants |
| No TAP Block | Length of Stay | 96 hours | 0 Participants |
| No TAP Block | Length of Stay | 72 hours | 1 Participants |
Secondary
Nausea
Number of participants with presence or absence of nausea reported and recorded by the nurse.
Time frame: 24 hours post surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine TAP Block | Nausea | 27 Participants |
| Regular Bupivacaine TAP Block | Nausea | 41 Participants |
| No TAP Block | Nausea | 34 Participants |
Secondary
NSAID Usage
Total amount of NSAID (ketorolac) use for analgesia.
Time frame: During hospitalization, up to 7 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | NSAID Usage | 14.2 Miligrams | Standard Deviation 30.2 |
| Regular Bupivacaine TAP Block | NSAID Usage | 42.5 Miligrams | Standard Deviation 21.5 |
| No TAP Block | NSAID Usage | 21.3 Miligrams | Standard Deviation 30.5 |
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.
Time frame: 24 hours post surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Pain Score | 4.3 units on a scale | Standard Deviation 1.7 |
| Regular Bupivacaine TAP Block | Pain Score | 4.7 units on a scale | Standard Deviation 1.7 |
| No TAP Block | Pain Score | 4.7 units on a scale | Standard Deviation 1.5 |
Secondary
Time to Ambulation
Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP Block | Time to Ambulation | 51 Hours | Standard Deviation 1.7 |
| Regular Bupivacaine TAP Block | Time to Ambulation | 60 Hours | Standard Deviation 1.6 |
| No TAP Block | Time to Ambulation | 59 Hours | Standard Deviation 2 |