Acute Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGliposomal bupivacaine
patients will receive a tap with liposomal bupivacaine
DRUGbupivacaine
patients will receive a tap with bupivacaine
Sponsors
University of Minnesota
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
* presenting for donor nephrectomy
Exclusion criteria
* non english speaking * chronic pain condition * taking chronic opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | 48-72 hours after injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Opioid Use | 48-72 hours | — |
| Number of Patients With Post Operative Nausea/Vomiting | 0-72 hours | — |
| Post Operative Length of Stay | up to 30 days after surgery | — |
| Postoperative Opioid Use | 24-48 hours | Use of opioids during 24-48 hours after surgery |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine TAP Patients will receive a TAP block with liposomal bupivacaine
liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine | 30 |
| Bupivacaine TAP Patients will receive a TAP block with bupivacaine
bupivacaine: patients will receive a tap with bupivacaine | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Bupivacaine TAP | Total | Liposomal Bupivacaine TAP |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 57 Participants | 29 Participants |
| Region of Enrollment United States | 29 participants | 59 participants | 30 participants |
| Sex: Female, Male Female | 19 Participants | 35 Participants | 16 Participants |
| Sex: Female, Male Male | 10 Participants | 24 Participants | 14 Participants |
| weight | 75.5 kilograms STANDARD_DEVIATION 15.5 | 77.1 kilograms STANDARD_DEVIATION 13.9 | 78.7 kilograms STANDARD_DEVIATION 12.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
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.
Time frame: 48-72 hours after injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Numerical Rating Scale | 5 scores on a scale |
| Bupivacaine TAP | Numerical Rating Scale | 3 scores on a scale |
Secondary
Number of Patients With Post Operative Nausea/Vomiting
Time frame: 0-72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine TAP | Number of Patients With Post Operative Nausea/Vomiting | 7 participants |
| Bupivacaine TAP | Number of Patients With Post Operative Nausea/Vomiting | 15 participants |
Secondary
Post Operative Length of Stay
Time frame: up to 30 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Post Operative Length of Stay | 67.7 HOURS |
| Bupivacaine TAP | Post Operative Length of Stay | 78.1 HOURS |
Secondary
Postoperative Opioid Use
Use of opioids during 24-48 hours after surgery
Time frame: 24-48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Postoperative Opioid Use | 190 Micrograms of fentanyl equivalents |
| Bupivacaine TAP | Postoperative Opioid Use | 240 Micrograms of fentanyl equivalents |
Secondary
Post Operative Opioid Use
Time frame: 48-72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Post Operative Opioid Use | 70 micrograms of fentanyl equivalents |
| Bupivacaine TAP | Post Operative Opioid Use | 170 micrograms of fentanyl equivalents |
Secondary
Post Operative Opioid Use
Post operative opioid use from 0-24 hours after surgery.
Time frame: 0-24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Post Operative Opioid Use | 160 micrograms of fentanyl equivalents |
| Bupivacaine TAP | Post Operative Opioid Use | 230 micrograms of fentanyl equivalents |