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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal bupivacaine TAP | Experimental | these patients receive a subcostal TAP with liposomal bupivacaine |
|
| bupivacaine TAP | Active Comparator | These patients receive a subcostal TAP with bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug |
| ||
| liposomal bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Opioid Use | To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block | 0-72 hours after injection |
| 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 |
| Post Operative Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26056753 | Derived | Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine TAP | these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine |
| FG001 | Bupivacaine TAP | These patients receive a subcostal TAP with bupivacaine Bupivacaine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine TAP | these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine |
| BG001 | Bupivacaine TAP | These patients receive a subcostal TAP with bupivacaine Bupivacaine |
| 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 | Post Operative Opioid Use | To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block | Posted | Median | Full Range | micrograms of fentanyl equivalents | 0-72 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 | these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Hutchins | University of MInnesota | 6126249990 | 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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|
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block |
| 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. | assessed at 72 hours after injection |
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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 | Full Range | scores on a scale | 48-72 hours |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Hours | up to 30 days after surgery |
|
|
|
| Secondary | 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. | Posted | Number | participants satisfied with pain control | assessed at 72 hours after injection |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Bupivacaine TAP | These patients receive a subcostal TAP with bupivacaine Bupivacaine | 0 | 30 | 0 | 30 |
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| D000588 |
| Amines |