A Phase 4 interventional study of Liposomal Bupivacaine and Bupivacaine in Acute Pain, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.
This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.
In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.
A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 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 the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side.
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures.
Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 87 is close to 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.
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Exclusion Criteria
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.
Drug: Liposomal Bupivacaine · Device: Ultrasound · Drug: Epinephrine · Drug: acetaminophen · Drug: ibuprofen · Drug: Oxycodone
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
Drug: Bupivacaine · Device: Ultrasound · Drug: acetaminophen · Drug: ibuprofen · Drug: Oxycodone
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.
Also known as: Exparel
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.
all individuals will receive scheduled acetaminophen (1 gram every 6 hours),
all individuals will receive scheduled ibuprofen (800 mg every 8 hours)
all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
Total Opioid Use for Pain Control
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
Time frame: 72 hours
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.
Time frame: 0-72 hours post-procedure
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Time frame: 0-24 post-procedure
Quality of Recovery 15 (QoR15) Score
The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.
Time frame: 72 hours post-procedure
Overall Benefit of Analgesia Score (OBAS)
The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.
Time frame: 72 hours post-procedure
Number of Participants With Nausea and Vomiting
Time frame: 72 hours post-procedure
Length of Time in Phase 1 and Phase 2 of Recovery
time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.
Time frame: an expected average of 120 mins
Number of Patients Admitted Post Operatively
Time frame: 72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery
opioids in mg of morphine equivalents used from 24-48 hours after surgery
Time frame: 24-48 hours after the end of surgery
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
opioid use from time 48-72 hours in mg morphine equivalents
Time frame: 48-72 hours after end of surgery
Patient Satisfaction With Pain Management
number of patients who answered yes to if they were satisfied with their pain management
Time frame: at 72 hours after surgery
Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Time frame: 0-24 hours after surgery
Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Time frame: 24-48 hours after surgery
Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Time frame: 48-72 hours after surgery
| Milestone | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Started | 49 | 38 |
| Completed | 31 | 31 |
| Not completed | 18 | 7 |
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
| mg Morphine equivalents | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Total Opioid Use for Pain Control | 20.8 (0 to 66) | 25.0 (5 to 72) |
the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.
| scores on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10) | 8 (0 to 29) | 13 (3 to 30) |
| mg of morphine equivalents | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents | 7.5 (0 to 55) | 22.5 (0 to 90) |
The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.
| scores on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Quality of Recovery 15 (QoR15) Score | 126 (79 to 146) | 115 (65 to 136) |
The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.
| scores on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | 2 (0 to 10) | 3 (0 to 11) |
| Participants | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Number of Participants With Nausea and Vomiting | 10 | 16 |
time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.
| hours | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Length of Time in Phase 1 and Phase 2 of Recovery | 3.3 (1 to 8) | 3.1 (1 to 9) |
| Participants | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Number of Patients Admitted Post Operatively | 11 | 16 |
opioids in mg of morphine equivalents used from 24-48 hours after surgery
| mg of morphine equivalents | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Opioid Used From 24-48 Hours Post Surgery | 0 (0 to 45) | .5 (0 to 38) |
opioid use from time 48-72 hours in mg morphine equivalents
| mg morphine equivalents | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents | 0 (0 to 25) | 5 (0 to 34) |
number of patients who answered yes to if they were satisfied with their pain management
| Participants | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Patient Satisfaction With Pain Management | 30 | 24 |
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
| units on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Maximal Pain Score of Patient From Time 0-24 Hours After Surgery | 3 (0 to 10) | 5 (2 to 10) |
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
| units on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Maximal Pain Score for Patient From Time 24-48 Hours After Surgery | 3 (0 to 9) | 4 (0 to 10) |
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
| units on a scale | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| Maximal Pain Score Patient Felt From 48-72 Hours After Surgery | 2 (0 to 10) | 3 (0 to 10) |
Collected over adverse event data was kept up to 30 days after surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAP-Block With Liposomal Bupivacaine | 0/31 (0%) | 0/31 (0%) | 10/31 (32.3%) |
| Surgical Infiltration With Bupivacaine | 0/31 (0%) | 0/31 (0%) | 16/31 (51.6%) |
| Event | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine |
|---|---|---|
| nausea/vomitingGastrointestinal disorders | 10/31 | 16/31 |
| Age, Continuous(years) | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine | Total |
|---|---|---|---|
| Median | 58 (32 to 77) | 62 (32 to 88) | 59 (32 to 88) |
| Sex: Female, Male(Participants) | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine | Total |
|---|---|---|---|
| Female | 31 | 31 | 62 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | TAP-Block With Liposomal Bupivacaine | Surgical Infiltration With Bupivacaine | Total |
|---|---|---|---|
| United States | 31 | 31 | 62 |
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