A Phase 4 interventional study of Bupivacaine and liposomal bupivacaine in Acute Pain, sponsored by University of Minnesota. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment
The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.
Treatment technique:
The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.
When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score.
If patients have met criterion for discharge to home including pain \<4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement.
If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred.
Adequate analgesia will be defined as \<3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
these patients receive a subcostal TAP with liposomal bupivacaine
Drug: liposomal bupivacaine
These patients receive a subcostal TAP with bupivacaine
Drug: Bupivacaine
Post Operative Opioid Use
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
Time frame: 0-72 hours after injection
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
Post Operative Length of Stay
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
Time frame: up to 30 days after surgery
Patient Satisfaction as Assessed Via Patient Survey
To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
Time frame: assessed at 72 hours after injection
| Milestone | Liposomal Bupivacaine TAP | Bupivacaine TAP |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 29 |
| Not completed | 2 | 1 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
| micrograms of fentanyl equivalents | Liposomal Bupivacaine TAP | Bupivacaine TAP |
|---|---|---|
| Post Operative Opioid Use | 24.9 (0 to 86.7) | 51.7 (0 to 249.7) |
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.
| scores on a scale | Liposomal Bupivacaine TAP | Bupivacaine TAP |
|---|---|---|
| Numerical Rating Scale | 3 (0 to 8) | 5 (0 to 10) |
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
| Hours | Liposomal Bupivacaine TAP | Bupivacaine TAP |
|---|---|---|
| Post Operative Length of Stay | 11 ± 9.1 | 17 ± 13.9 |
To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
| participants satisfied with pain control | Liposomal Bupivacaine TAP | Bupivacaine TAP |
|---|---|---|
| Patient Satisfaction as Assessed Via Patient Survey | 26 | 24 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposomal Bupivacaine TAP | — | 0/28 (0%) | 0/28 (0%) |
| Bupivacaine TAP | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Liposomal Bupivacaine TAP | Bupivacaine TAP | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 25 | 45 |
| >=65 years | 8 | 5 | 13 |
| Sex: Female, Male(Participants) | Liposomal Bupivacaine TAP | Bupivacaine TAP | Total |
|---|---|---|---|
| Female | 28 | 30 | 58 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liposomal Bupivacaine TAP | Bupivacaine TAP | Total |
|---|---|---|---|
| United States | 28 | 30 | 58 |
| weight(kilograms) | Liposomal Bupivacaine TAP | Bupivacaine TAP | Total |
|---|---|---|---|
| Mean | 89.3 ± 25.1 | 98.5 ± 34.2 | 93.5 ± 30.2 |
No study locations are listed for this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota