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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine only | Active Comparator | 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. |
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| Liposomal Bupivacaine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Hours,12, 48, and 72 |
| Mean Average Morphine Equivalences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrahman Nimeri, MD | Wake Forest University Health Sciences, Atrium Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17961838 | Background | McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011. | |
| 19059927 | Background | Mukhtar K, Singh S. Transversus abdominis plane block for laparoscopic surgery. Br J Anaesth. 2009 Jan;102(1):143-4. doi: 10.1093/bja/aen338. No abstract available. |
| Label | URL |
|---|---|
| Patient survey app distribution website | View source |
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3 of the subjects were not randomized or assigned
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 7, 2023 |
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This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.
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Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.
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| Bupivacaine Injection | Drug | Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine |
|
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Morphine milligram equivalences consumed during hospital stay |
| Day 3 |
| Morphine Equivalences - Week 1 | Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit | Week 1 |
| 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) | Week 1 |
| Length of Hospital Stay | Hospital length of stay in hours | Day 3 |
| 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." | Day 30 |
| 32709581 | Background | Hamid HKS, Ahmed AY, Saber AA, Emile SH, Ibrahim M, Ruiz-Tovar J. Transversus abdominis plane block using a short-acting local anesthetic reduces pain and opioid consumption after laparoscopic bariatric surgery: a meta-analysis. Surg Obes Relat Dis. 2020 Sep;16(9):1349-1357. doi: 10.1016/j.soard.2020.04.023. Epub 2020 Apr 24. |
| 33687173 | Background | Jin Z, Ding O, Islam A, Li R, Lin J. Comparison of Liposomal Bupivacaine and Conventional Local Anesthetic Agents in Regional Anesthesia: A Systematic Review. Anesth Analg. 2021 Jun 1;132(6):1626-1634. doi: 10.1213/ANE.0000000000005406. |
| FG001 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| 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, Customized | Mean | Full Range | Number of 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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| 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 | 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. | 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. | Posted | Mean | Full Range | score on a scale | Hour 24 |
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| 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 | 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 | Posted | Mean | Full Range | score on a scale | Hours,12, 48, and 72 |
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| Secondary | Mean Average Morphine Equivalences | Morphine milligram equivalences consumed during hospital stay | Posted | Mean | Full Range | Morphine Milligram Equivalents | Day 3 |
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| Secondary | Morphine Equivalences - Week 1 | Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit | 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. | Posted | Week 1 |
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| 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) | 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. | Posted | Week 1 |
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| Secondary | Length of Hospital Stay | Hospital length of stay in hours | Posted | Mean | Full Range | hours | Day 3 |
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| 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." | 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. | Posted | Day 30 |
|
Week 1
subjects being non-compliant
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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 | 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 | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | 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 | 0 | 34 | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Selwan Barbat, MD | Wake Forest University Health Sciences | 704-355-2000 | Selwan.Barbat@atriumhealth.org |
| Dec 3, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2023 | Dec 3, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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