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The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.
Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen.
Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal bupivacaine TAP | Experimental | Patients will receive a TAP block with liposomal bupivacaine |
|
| bupivacaine TAP | Active Comparator | Patients will receive a TAP block with bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivacaine | Drug | patients will receive a tap with liposomal bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale | This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period. | 48-72 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Opioid Use | 48-72 hours | |
| Number of Patients With Post Operative Nausea/Vomiting | 0-72 hours | |
| Post Operative Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine TAP | Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline. |
| FG001 | Bupivacaine TAP | Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
we analyzed patients age, weight and gender.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine TAP | Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine |
| BG001 | Bupivacaine TAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Numerical Rating Scale | This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period. | Posted | Median | Inter-Quartile Range | scores on a scale | 48-72 hours after injection |
|
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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 | Patients will receive a TAP block with liposomal bupivacaine liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Hutchins | University of Minnesota | 612-624-9990 | hutc0079@umn.edu |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| bupivacaine | Drug | patients will receive a tap with bupivacaine |
|
| up to 30 days after surgery |
| Postoperative Opioid Use | Use of opioids during 24-48 hours after surgery | 24-48 hours |
| Post Operative Opioid Use | Post operative opioid use from 0-24 hours after surgery. | 0-24 hours |
Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | kilograms |
|
|
|
| Secondary | Post Operative Opioid Use | Posted | Median | Inter-Quartile Range | micrograms of fentanyl equivalents | 48-72 hours |
|
|
|
| Secondary | Number of Patients With Post Operative Nausea/Vomiting | Posted | Number | participants | 0-72 hours |
|
|
|
| Secondary | Post Operative Length of Stay | Posted | Median | Inter-Quartile Range | HOURS | up to 30 days after surgery |
|
|
|
| Secondary | Postoperative Opioid Use | Use of opioids during 24-48 hours after surgery | Posted | Median | Inter-Quartile Range | Micrograms of fentanyl equivalents | 24-48 hours |
|
|
|
| Secondary | Post Operative Opioid Use | Post operative opioid use from 0-24 hours after surgery. | Posted | Median | Inter-Quartile Range | micrograms of fentanyl equivalents | 0-24 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Bupivacaine TAP | Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine | 0 | 29 | 0 | 29 |
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| D000588 |
| Amines |