Bariatric Surgery Candidate, Morbid Obesity
Conditions
Keywords
Transversus Abdominis Plane (TAP) block, Bupivacaine, Liposomal bupivacaine
Brief summary
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.
Detailed description
Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.
Interventions
DRUGLiposomal bupivacaine
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
DRUGBupivacaine Injection
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.
Intervention model description
This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * Participants who can give written informed consent and willing to comply with all study-related procedures. * Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass
Exclusion criteria
* Patients undergoing duodenal switch procedures * Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery * Patients with chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24 Hour Visual Analogue Scale (VAS) Pain Score | Hour 24 | Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Average Morphine Equivalences | Day 3 | Morphine milligram equivalences consumed during hospital stay |
| Morphine Equivalences - Week 1 | Week 1 | Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit |
| Mean Visual Analogue Scale (VAS) Pain Scores | Hours,12, 48, and 72 | Pain score at 12 hours, 48 hours, and 72 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine |
| Length of Hospital Stay | Day 3 | Hospital length of stay in hours |
| Patient Satisfaction Scores | Day 30 | Patient Satisfaction score based on daily postop online surveys - These parameters will be scored via SeamlessMD on a phone application, as well as paper and pen on a standardized reporting form for patients less comfortable using technology - scored on a scale of 0-10, with 0 being worst surgeon possible and 10 being best surgeon possible. |
| Post-operative Nausea and Vomiting (PONV) | Week 1 | Post-operative nausea and vomiting (PONV) measured by a numerical score (1: no nausea or vomiting, 2: some nausea no vomiting, 3: nausea and vomiting) |
Countries
United States
Participant flow
Pre-assignment details
3 of the subjects were not randomized or assigned
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Only Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine | 35 |
| Liposomal Bupivacaine Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not being compliant with the Seamless MD app | 31 | 30 |
| Overall Study | revisional surgery | 4 | 2 |
| Overall Study | surgeries were cancelled | 0 | 2 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Total | Bupivacaine Only |
|---|---|---|---|
| Age, Customized | 43 Number of years | 43.5 Number of years | 44 Number of years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 37 Participants | 19 Participants |
| Sex: Female, Male Female | 32 Participants | 63 Participants | 31 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
Mean 24 Hour Visual Analogue Scale (VAS) Pain Score
Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine.
Time frame: Hour 24
Population: The numbers analyzed meaning those who received the bupivacaine or not were 35 and 34 However, the Post-Anesthesia Care Unit team nurses did not obtain pain scores on everyone so what is listed is the data of what we had, which is less. This is why it doesn't add up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine Only | Mean 24 Hour Visual Analogue Scale (VAS) Pain Score | 1 score on a scale |
| Liposomal Bupivacaine | Mean 24 Hour Visual Analogue Scale (VAS) Pain Score | 3 score on a scale |
Secondary
Length of Hospital Stay
Hospital length of stay in hours
Time frame: Day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine Only | Length of Hospital Stay | 24.5 hours |
| Liposomal Bupivacaine | Length of Hospital Stay | 29.7 hours |
Secondary
Mean Average Morphine Equivalences
Morphine milligram equivalences consumed during hospital stay
Time frame: Day 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivacaine Only | Mean Average Morphine Equivalences | Intraoperative Administration Bupivacaine: up to 24 hours Liposomal Bupivacaine: up to 25 hours | 11.67 Morphine Milligram Equivalents |
| Bupivacaine Only | Mean Average Morphine Equivalences | Floor Admin/Subject Room Bupivacaine: up to 6 hours Liposomal Bupivacaine: up to 22.5 hour | 3.8 Morphine Milligram Equivalents |
| Bupivacaine Only | Mean Average Morphine Equivalences | Post Anesthesia Care Unit (PACU) Bupivacaine: up to 9 hours Liposomal Bupivacaine: up to 6 hours | 4.67 Morphine Milligram Equivalents |
| Liposomal Bupivacaine | Mean Average Morphine Equivalences | Intraoperative Administration Bupivacaine: up to 24 hours Liposomal Bupivacaine: up to 25 hours | 13.1 Morphine Milligram Equivalents |
| Liposomal Bupivacaine | Mean Average Morphine Equivalences | Post Anesthesia Care Unit (PACU) Bupivacaine: up to 9 hours Liposomal Bupivacaine: up to 6 hours | 3.43 Morphine Milligram Equivalents |
| Liposomal Bupivacaine | Mean Average Morphine Equivalences | Floor Admin/Subject Room Bupivacaine: up to 6 hours Liposomal Bupivacaine: up to 22.5 hour | 5.61 Morphine Milligram Equivalents |
Secondary
Mean Visual Analogue Scale (VAS) Pain Scores
Pain score at 12 hours, 48 hours, and 72 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine
Time frame: Hours,12, 48, and 72
Population: Difference in Number of Subjects at different Hours due to subjects being non-compliant: not entering information into Seamless MD app; data not being collected The numbers analyzed meaning those who received the bupivacaine or not were 35 and 34 However, the Post-Anesthesia Care Unit team nurses did not obtain pain scores on 6 Subjects in Bupivacaine Group and 7 Subjects in the Liposomal Bupivacaine Group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivacaine Only | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 12 | 4.4 score on a scale |
| Bupivacaine Only | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 48 | 5.7 score on a scale |
| Bupivacaine Only | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 72 | 2.5 score on a scale |
| Liposomal Bupivacaine | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 12 | 5.64 score on a scale |
| Liposomal Bupivacaine | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 48 | 5.6 score on a scale |
| Liposomal Bupivacaine | Mean Visual Analogue Scale (VAS) Pain Scores | Hour 72 | 7.0 score on a scale |
Secondary
Morphine Equivalences - Week 1
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
Time frame: Week 1
Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD Mean Morphine Milligram Equivalents (MME) use and lack of compliance of clinic obtaining this data and submitting into redcap.
Secondary
Patient Satisfaction Scores
Patient Satisfaction score based on daily postop online surveys - These parameters will be scored via SeamlessMD on a phone application, as well as paper and pen on a standardized reporting form for patients less comfortable using technology - scored on a scale of 0-10, with 0 being worst surgeon possible and 10 being best surgeon possible.
Time frame: Day 30
Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD MME use and lack of compliance of clinic obtaining this data and submitting into redcap.
Secondary
Post-operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting (PONV) measured by a numerical score (1: no nausea or vomiting, 2: some nausea no vomiting, 3: nausea and vomiting)
Time frame: Week 1
Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD MME use and lack of compliance of clinic obtaining this data and submitting into redcap.